Exact Sciences Corp., Seekin Inc. and Serum Detect Inc. presented encouraging results for the field of multicancer early detection at the American Association for Cancer Research annual meeting in San Diego April 6-10, but delays in coverage may slow further progress.

Australia’s Speedx Pty Ltd. is launching a new rapid polymerase chain reaction (qPCR) test for 14 different respiratory viruses in a single test that works on almost every commercial PCR platform in half the time and at a fraction of the cost of what its competitors charge.

The U.S. FDA and Department of Justice have announced a consent decree entered into district court that enjoins Philips Respironics LLC North America from manufacturing and distributing respiratory devices from three company facilities in the state of Pennsylvania.

While the notion of a medical device single review program is still more aspirational than respirational, a number of nations are shifting incrementally toward mutual recognition for medical devices.

The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency.

Top of FormMed-tech financings in March totaled $1.79 billion. Although a decline from February’s total, the cumulative value for the first three months of the year reached $6.02 billion, an increase from $4.69 billion during the same period the previous year.

Medtronic plc reported data from a head-to-head trial backing its Evolut TAVR system against competitor Edwards Lifesciences Corp.’s Sapien platform, and the data showed particular promise of the Evolut in patients with a small aortic annulus, which would appear to be most beneficial for women in particular.