Insulet Corp. once again broke records with a nearly 50% increase in Omnipod revenues in U.S. in the first quarter and a 32% increase in revenue from the tubeless insulin delivery device worldwide. In an unusual move following such positive quarterly results, the company simultaneously announced a major shake-up in the leadership team, with multiple senior members moving to new positions starting July 1. The latest round of musical chairs comes almost exactly a year after the last at the Insulet, when Founder, President and CEO Shacey Petrovic stepped down and Jim Hollingshead assumed the top spot. Read More
Magenta Medical Ltd. has raised $55 million to fast-track the development of the world’s smallest left ventricular assist device (LVAD). The financing round was led by Orbimed Private Investment LLC. With the participation of existing investors, New Enterprise Associates, Pitango VC Ltd. and Alive MS Ltd. “We will use this funding, in particular, to advance the clinical programs in the U.S. towards our first FDA approval,” David Israeli, CEO of Magenta Medical, told BioWorld. Read More
Anhui Happiness Workshop Medical Equipment Co. Ltd.'s single use ureteroscope was approved by China’s NMPA, becoming the first domestically developed electronic soft ureteroscope to monitor intrarenal pressure during procedures. Read More
Citing significant concerns of bacterial contamination, the FDA urged consumers and health care providers to stop using specific lots of SD Biosensor Inc.’s Pilot COVID-19 At-Home Tests, which were distributed by Roche Diagnostics Systems Inc. The agency warned that direct contact with the contaminated liquid solution could pose safety issues as well as impair the test’s performance. Read More
Even though COVID-19 is transitioning from pandemic to endemic across the world, it will remain first in mind as U.S. lawmakers look to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year to ensure the country is better prepared for future threats. With a Sept. 30 deadline for reauthorizing PAHPA, the Senate Health, Education, Labor and Pensions (HELP) Committee has its work cut out for it. But it won’t be starting from scratch. In opening a May 4 hearing on the reauthorization, HELP Chair Bernie Sanders (I-Vt.) said the committee would build on the efforts started last year under then-Chair Patty Murray (D-Wash.) and now-retired Ranking Member Richard Burr (R-N.C.). Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: ASP Isotopes, Baxter, CC Nuclear, Creative Foam, Glaukos, Orbusneich, Probo, RC14, Scopio Labs, Siemens Healthineers. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eyenovia, Happe Spine, Neuronetics. Read More
