The U.S. FDA’s authority to require cybersecurity measures in premarket submissions is a radical change for industry, but firms must document that they have erected solid cybersecurity measures.

In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.

The use of Renalytix plc’s Kidneyintelx biomarker-based prognostic test led to increased and targeted use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients at risk of diabetic kidney disease, compared to untested patients, according to data from a study.

Staffing cuts at the FDA’s device center led to speculation that the current user fee program may be fatally damaged, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in a meeting in Columbus, Ohio that there are too many resources for FDA at stake for the user fee program to be ended.

The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.

If U.S. sectoral tariffs on biopharmaceuticals become a reality and most country-by-country tariffs on other medical products resume, manufacturers may have to rethink their use of U.S. free trade zones to turn foreign-sourced active pharmaceutical ingredients and other components into finished products for the U.S. market.

Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.

The European Association of Medical Device Notified Bodies inked a position paper on the EU Artificial Intelligence Act which recites some standing concerns. Perhaps the most interesting passage in the paper is that there is a need for a “well-coordinated approach between member states that are in charge of notified body oversight.”

Medtronic plc’s diabetes unit posted another win with the U.S. FDA approval of the Simplera continuous glucose monitoring sensor for use with the Minimed 780G pump system, helping the company catch up with competitors Abbott Laboratories and Dexcom Inc. Medtronic plans to begin a limited launch of the Simplera Sync in the U.S. this fall.

The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.