pharmaphorum

SEPTEMBER 22, 2021

The software – called Paige Prostate – is the first artificial intelligence-based to be approved by the FDA for this purpose, according to the US regulator. The results found that Paige Prostate – developed by Paige (formerly known as Paige.AI ) – improved detection of cancer on individual slide images by 7.3%

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In-Vitro Radiology Regulation Trials 108

pharmaphorum

FEBRUARY 3, 2021

France’s SurgAR has joined with imaging data firm Medexprim to form a three-year partnership with a major hospital in France, to develop augmented reality (AR) software dedicated to laporoscopic surgery. The information comes from preoperative radiological imaging data and aims to guide the surgeon during operations, increasing precision.

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Radiology Compliance Doctor Doctors 69

FDA Law Blog

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That Rule requires data companies to notify consumers and regulators of unauthorized disclosures of consumers’ personal health information.

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FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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Regulation Radiology Cosmetics Compliance 59

FDA Law Blog

NOVEMBER 17, 2022

Koblitz — As was introduced in our recent blog post summarizing the 2022 MedTech conference ( here ), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot ( see announcement attributed to CDRH director Jeff Shuren, M.D.,

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XTalks

OCTOBER 26, 2022

The life cycle of a medical device encompasses several phases, initiating from the spark of a feasible idea of the device’s design, followed by an analysis of patients’ need for the plausible device, development and validation of medical device’s design, approval from the regulatory agency, a launch of the device and finally post-market research.

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pharmaphorum

DECEMBER 11, 2022

It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. As we develop these technologies, it’s not only that we must focus on the patient experience; we need to start with the patient experience,” Hadjiat tells pharmaphorum.

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pharmaphorum

SEPTEMBER 8, 2022

Furthering DiME’s previous work on digital clinical measures, nocturnal scratch’s more widespread implementation aims to establish a firmer digital groundwork for future clinical research, technology development, and reimbursement decisions in the dermatological field, and thereby improve the lives of AD patients and caregivers.

Dermatology 52

Dermatology Production Radiology Development 52

FDA Law Blog

NOVEMBER 21, 2022

One cause of death in this “valley” is related to the need to understand and meet regulator expectations. The TAP Pilot will build on the CDRH’s experience engaging with developers during the COVID-19 pandemic through the pre-EUA pathway, as well as the Agency’s experience with the Breakthrough Devices and Early Feasibility Study Programs.

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Regulation Production Radiology Development 59

XTalks

SEPTEMBER 9, 2022

The California-based medical device company develops brain stimulation technology to treat neuropsychiatric disorders. George, MD, distinguished professor of Psychiatry, Radiology and Neuroscience, and director of the Brain Stimulation Division, Psychiatry at the Medical University of South Carolina, in Magnus Medical’s press release.

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Radiology Life Science Licensing Licensing 98

XTalks

MAY 21, 2024

Collaborative efforts with the International Council for Harmonisation (ICH) and the International Medical Device Regulators Forum are pivotal in this regard. Device and Radiological Health Innovations In October 2023, the FDA’s Center for Devices and Radiological Health has celebrated a decade of the Early Feasibility Studies (EFS) Program.

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Clinical Trials Clinical Trials Trials Clinical Research 64

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Clinical Trials 59

Clinical Trials Clinical Trials Insulin Radiology 59

XTalks

APRIL 6, 2021

The device, developed by world-leading medical technology company Medtronic , is indicated for both pediatric and adult patients who have severe pulmonary valve regurgitation. Related: First AI-Guided Ultrasound for Cardiac Imaging Approved by Regulators.

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FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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Development Drugs Clinical Trials Clinical Trials 52

FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

In-Vitro 69

In-Vitro Regulation Production Development 69

FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

Radiology 40

Radiology Production Regulation Manufacturing 40

The Pharma Data

APRIL 15, 2022

director of the FDA’s Center for Devices and Radiological Health. The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”. Source link: [link].

Radiology 52

Radiology Cosmetics Production Licensing 52

XTalks

AUGUST 30, 2022

One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Why is it Difficult to Develop CNS Therapeutics? Intrathecal Drug Systems are an Important Pain Treatment Modality.

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Trials Drug Delivery Drugs Gene 83

FDA Law Blog

OCTOBER 10, 2022

The final CDS Guidance represents a marked change in approach from prior drafts and foreseeably will result in the regulation of many types of CDS that were previously considered to be Non-Device CDS or low-risk Device CDS under enforcement discretion.

Regulation 52

Regulation In-Vitro Development Radiology 52

Delveinsight

SEPTEMBER 2, 2021

This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market approval (PMA) application.

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Marketing Radiology Drugs Drug Delivery 72

XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. With a network including North America, Europe and Asia, Curia aims to improve patient outcomes and quality of life by offering a complete suite of solutions across its three divisions: Discovery, Development and Analytical (DDA), Drug Product and API Manufacturing.

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Packaging Packaging Containment Production 98

The Pharma Data

APRIL 20, 2022

director of the FDA’s Center for Devices and Radiological Health. All NIPS tests on the market today are offered as laboratory developed tests (LDTs). Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. Source link: [link].

Genetics 52

Genetics Cosmetics Radiology Production 52

XTalks

NOVEMBER 7, 2022

In addition, Dr. Bahassi stressed that the simple enumeration of CTCs will not contribute significantly to the development of improved or more personalized cancer treatments. During the webinar, Dr. Bahassi gave a brief schematic of how personalized, targeted assays can be developed to detect somatic mutations from cfDNA ( Figure 1 ).

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Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

NOVEMBER 17, 2020

director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.” ” An important component to successful at-home testing is the ability to efficiently track and monitor results.

Radiology 40

Radiology Cosmetics Production Doctor 40

The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations. Source link: [link].

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The Pharma Data

NOVEMBER 6, 2020

director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. The FDA granted the marketing authorization to Nightware, Inc.

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Marketing Production Radiology Regulation 40

XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. The company reported an investment of $2.7

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pharmaphorum

MARCH 16, 2021

The use of real-world evidence is proving beneficial for pharma and medical devices companies across the lifecycle of development from R&D to re-purposing. It’s a statistical model, which by design, guarantees confidentiality and satisfies the requirements of Hospital ethics committees, NHS regulations and Life Science industry policies.

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The Pharma Data

OCTOBER 14, 2020

Felker and Dr. Udelson join current advisors to support the development ofalfapump ® DSR for the management of fluid overload in patients with heart failure. The Sequana Medical management team is working closely with its advisors on the development of alfa pump DSR (Direct Sodium Removal). GHENT, Belgium, Oct.

Cardiology 40

Cardiology Clinical Trials Clinical Trials Medicine 40

The Pharma Data

FEBRUARY 23, 2022

director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.

Marketing 52

Marketing Clinical Trials Clinical Trials Radiology 52

FDA Law Blog

NOVEMBER 6, 2024

As the Court explains, an orphan drug may not be the “same drug” as the same active moiety under the Orphan Drug Act and FDA’s longstanding implementing regulations if one is “clinically superior” than the other by way of greater efficacy, greater safety, or major contribution to patient care (“MC-to-PC”).

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Drugs Regulation Radiology Production 111

The Pharma Data

MAY 3, 2021

Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ). Coronavirus Pandemic.

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Gene Therapy Vaccination Vaccine Bioequivalency 52

XTalks

SEPTEMBER 14, 2020

And in truth, the companies the White House picked were pretty savvy as several are current front-runners in the race to develop a vaccine. The company is also in collaboration with Ridgeback Biotherapeutics to develop a novel oral antiviral treatment for COVID-19. helped protect COVID-19 patients against developing severe disease.

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