Cellecta Inc. made remote diagnostics and decentralized clinical trials significantly easier with the launch of its Drivermap Exp assay. The microsampling kit provides a “molecular snapshot” of 19,000 human protein-encoding genes from just 30 microliters of dried whole blood.

Q’apel Medical Inc., of Fremont, Calif., might have thought the company’s withdrawal of the Hippo catheter was nothing but a loss, but Route 92 Medical Inc. managed to shine a positive light on the withdrawal by dropping a patent lawsuit against Q’apel because of the Hippo device.

Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.

In an ongoing effort to onshore more of the biopharma supply chain, U.S. President Donald Trump signed an executive order (EO) late May 5 to shorten the time involved in bringing a new manufacturing plant or expansion online and to remove some of the incentives for foreign production of finished drugs and active pharmaceutical ingredients.

Claiming that they’re suffering the consequences of a March 27 directive ordering a mass reduction in force and reorganization throughout the U.S. Department of Health and Human Services (HHS), 19 states and the District of Columbia took their grievances to court.

April data and first quarter earnings reports show remarkable resilience in med tech, even as other sectors continue to suffer in response to tariffs and changing regulations. Not that tariffs proved insignificant: several companies reported annualized impacts north of half a billion dollars, but fundamentals and increased interest in med tech as a haven gave most players sufficient breathing room to absorb the impact with minimal adjustments.

Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.

The U.S. Department of Justice may have dismantled its civil division, but that doesn’t mean companies in the life sciences can let their guard down.

Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.

Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.