Predetermined change control plans have potential to accelerate US FDA review timelines for device modifications, but visibility remains low as to whether the program is behaving as advertised and delivering efficiencies sought by sponsors. Joshua Oyster, partner in Ropes & Gray’s Washington, D.C. office, offers perspective.

The US Food and Drug Administration has granted a de novo authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first over-the-counter flu test to be cleared outside the emergency use pathway.

The US Food and Drug Administration is undergoing seismic leadership changes, from the expected post-election departure of two-term Commissioner Robert Califf to the retirement of longtime Center for Devices and Radiological Health Director Jeff Shuren. What might the new management mean for the medtech industry? Silverman Group President and former FDAer Steve Silverman has some insight.

FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements. 

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.

The results from a trio of studies show that AI-powered digital stethoscopes are effective at identifying patients at elevated risk of experiencing heart attacks and other major cardiac adverse events, according to Eko Health, whose technology was used to screen the participants in the studies.

Altoida CEO Mark Jones has high hopes that the company’s digital assessment tool will be approved by the FDA to be used along with blood biomarker testing by primary care doctors to help predict Alzheimer’s disease before patients show symptoms.

Altoida CEO Marc Jones spoke with Medtech Insight about the company’s investigational digital screening tool for Alzheimer’s and the dire need for better, more accessible precision neurology diagnostics as the global population ages, neurologist shortages worsen, and groundbreaking Alzheimer’s drugs change the treatment paradigm.

Predetermined change control plans have potential to accelerate US FDA review timelines for device modifications, but visibility remains low as to whether the program is behaving as advertised and delivering efficiencies sought by sponsors. Joshua Oyster, partner in Ropes & Gray’s Washington, D.C. office, offers perspective.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.

Spain-based Inbrain Neuroelectronics plans first-in-human study to show safety of its graphene-based technology in direct contact with human brain while also developing a second interface for treating Parkinson’s disease.

Genetic Analysis CEO Ronny Hermansen and Christina Casén, senior VP of clinical and medical affairs, discuss the company’s polymerase chain reaction (PCR)-based approach to gut microbiota profiling versus DNA sequencing, competitive landscape, and opportunities for supporting pharma R&D and assessing drug treatment success.

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room. 

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

Predetermined change control plans have potential to accelerate US FDA review timelines for device modifications, but visibility remains low as to whether the program is behaving as advertised and delivering efficiencies sought by sponsors. Joshua Oyster, partner in Ropes & Gray’s Washington, D.C. office, offers perspective.

The US Food and Drug Administration has granted a de novo authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first over-the-counter flu test to be cleared outside the emergency use pathway.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.

Artificial intelligence and digital in healthcare are among four key scientific development areas that will benefit from the support of the UK Regulatory Innovation Office, the launch of which was announced by the government on 8 October.

The US Food and Drug Administration is undergoing seismic leadership changes, from the expected post-election departure of two-term Commissioner Robert Califf to the retirement of longtime Center for Devices and Radiological Health Director Jeff Shuren. What might the new management mean for the medtech industry? Silverman Group President and former FDAer Steve Silverman has some insight.

FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements. 

Innovation in life sciences and UK NHS adoption of technology are high on UK’s political agenda in the post-election period. Projects at the MedTech Directorate and NICE, and support from the Office for Life Sciences, are playing into a renewed sense of optimism.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

The owner of a Chicago COVID-19 testing lab plead guilty to wire fraud for billing the government for COVID-19 tests that were not performed. Also, test developer Talis Biomedical agreed to pay $32.5m to settle a shareholder suit.

No longer a watchdog, the UK MHRA wants to be seen as an enabling regulator, using new methodologies and data sources to bring device innovations safely into use, says agency chief executive June Raine.

Spain-based Inbrain Neuroelectronics plans first-in-human study to show safety of its graphene-based technology in direct contact with human brain while also developing a second interface for treating Parkinson’s disease.