Under the US FDA’s voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send to the agency updated master files that detail novel sterilization processes without the need to submit a new 510(k). The goal is to move industry away from using ethylene oxide (EtO) to sterilize devices.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs will shut down on 30 September if Congress doesn’t act to renew them – but some US senators say the programs are wasteful and may funnel research overseas. 

Draft legislation out of the US Senate Health, Education, Labor and Pensions (HELP) Committee gives the FDA authority to regulate certain in vitro diagnostics known as laboratory developed tests.

The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.

Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.

The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used. 

The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.

Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.

Medtech companies will soon be able to reference an updated European version of the international risk management standard when proving compliance with the EU Medical Device Regulation.

Stockholm-based AI Medical Technology is developing Dermalyser, which can help doctor’s diagnose skin cancer using images of moles and lesions. The company is initially focused on Sweden and the Netherlands, but hopes to soon expand into new European markets and the US.

Medtech Insight spoke with XACT Robotics’ executive chairman Harel Gadot about plans for the FDA-cleared ACE robotic system and its market opportunities.

Cyted is using Medtronic’s cytosponge collection device combined with its own analysis platform to create a simple and cheap method to screen patients for early warning signs of esophageal cancer.

Patel announced in a statement he will join Google Health as senior director of global digital health strategy.

Nicholas co-founded Boston Scientific in 1979 with John Abele. He served as the company’s CEO from 1979 until 1999 and as chairman until 2016.

The US agency has issued an emergency use authorization to Labcorp for its over-the-counter test that detects COVID-19, flu and respiratory syncytial virus.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs will shut down on 30 September if Congress doesn’t act to renew them – but some US senators say the programs are wasteful and may funnel research overseas. 

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights AI trends in medtech, Exec Chats with iRhythm and medical robotics authority Moshe Shoham, and key FDA updates.

Medtech Insight caught up again with iRhythm CEO Quentin Blackford about his vision for the company as it plans for the next five to ten years of expansion in the remote cardiac monitoring and arrhythmia diagnostics market.

The CONCERTO trial will evaluate the company’s SING IMT, an upgrade of its 12-year-old WA IMT device, in up to 100 people in the US with age-related macular degeneration.

The company’s Exo Works system integrates with almost any point-of-care ultrasound device – not just Exo’s – to link ultrasound imaging to electronic medical records, hospital picture archiving, and communication systems.

J&J’s entry into the kidney stone management market will not threaten Boston Scientific’s leadership position in that market in the near-term, according to Wells Fargo analyst Larry Biegelsen.