The U.S. FDA’s device center hasn’t issued news bulletins or guidances in the past week, but the march of device recalls continues apace in the month of February.

In the first patenting from Lent Innovations LLC, the company’s founder, Anne Lent – an allergist and immunologist – describes their invention of an epinephrine auto-injector tailored to the specific needs of children to reduce the risk of use errors and incorrect injection technique.

The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”

In a move that the company, said demonstrates its commitment to investing in higher growth areas, Zimmer Biomet Holdings Inc. reported its plans to buy foot and ankle (F&A) orthopedic specialist Paragon 28 Inc. for an up-front payment of $13 a share in cash, corresponding to an equity value of approximately $1.1 billion and an enterprise value of approximately $1.2 billion.

Timing is everything. Just days after confirming a pause in the U.S. rollout of its Varipulse pulsed field ablation (PFA) catheter, Johnson & Johnson’s electrophysiology program received an epic reprieve from European regulators who granted the company’s dual-energy Thermacool Smarttouch SF catheter CE mark.

In early validation of widespread predictions of a robust year for M&A activity, Boston Scientific Corp. signed a definitive agreement to acquire the 74% of Bolt Medical Inc. it doesn’t already own for $443 million up front and up to $221 million in contingent milestone payments.

AI pulled in major financings and approvals for Asia med-techs in 2024 as Asia Pacific countries played to individual strengths to maximize AI’s applications in the health care sector. While breakaway AI technologies like OpenAI’s ChatGPT reshaped and boosted many industries, AI also drove major financings for APAC med-techs weathering a wider macroeconomic downturn, with AI-based companies accounting for five out of 11 IPOs tracked on BioWorld’s med-tech IPOs list.

Companies developing brain-computer interface (BCI) technologies certainly stepped up their activities this year with several starting to implant their devices into humans. After decades as an experimental technology pursued exclusively in research settings, BCI devices could be just a few years away from entering clinical practice – and investors are paying attention.

The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation.

Preliminary results from a trial demonstrated that Science Corp.’s Prima retina implant restored ‘form vision,’ including the ability to read in patients with vision loss. Originally developed at Stanford University and then advanced by Pixium Vision SA, Prima received U.S. FDA breakthrough device designation in April 2023.