Policy & Regulation

A new UK medtech survey sets out industry’s market access and regulatory concerns and makes clear where system users see the need for improvement. There are some grounds for optimism, but the MHRA’s planned rise in regulatory fees could undo some of the good work.

Achieving a balance between regulatory controls and promoting innovation is proving one of the biggest challenges that the EU is facing since the implementation of the MDR and IVDR. But there are ways through.

This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.

The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.

European Commission acts on call from industry for more guidance from notified bodies around innovation.

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.

The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.

The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.

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.  

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.

Richard Lowenthal, co-founder and CEO of ARS Pharmaceuticals, highlights the crucial unmet need for needle-free devices to treat type 1 allergic reactions, given challenges associated with current epinephrine injectors. Hear what’s next for the Neffy intranasal spray and ARS Pharmaceuticals.

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.

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.  

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.

With the reversal of the Chevron doctrine in June, lower courts will now have more say in deciding regulatory statutes when the language is murky. But will that open the door to more legal challenges from the healthcare industry against government regulations it finds unfavorable? A pair of legal experts recently discussed the potential implications of the Court’s decision.

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

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.

This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.

J&J’s “pants down” moment with Auris could permanently change how medtech M&A is conducted. Build-to-buy arrangements, which leave companies’ destinies in the hands of their owners, are likely to replace current earn-out models.