CereVasc announced today that it received a second FDA investigational device exemption (IDE) for its eShunt system. The IDE allows CereVasc to initiate a pilot trial of the eShunt system in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). The company received its first IDE to begin a trial of the eShunt for […]
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Steris shares drop on Q1 swing-and-miss, lowered outlook
Steris (NYSE:STE) posted first-quarter results today that fell short of the consensus forecast on Wall Street and reduced its outlook for the rest of the year, despite swinging to a profit from a loss a year ago. The infection prevention technology company — headquartered in Dublin, Ireland, and run operationally out of Mentor, Ohio — […]
Acutus Medical’s chief translational science officer is stepping down
Acutus Medical (Nasdaq:AFIB) Chief Translational Science Officer Dr. Steven Mickelsen recently announced he is stepping down to focus on patient care and new cardiac innovation. Mickelsen has been with the company for three years and led the design team to create a pulsed field ablation waveform to expand the capabilities of the company’s AcQblate contact-force ablation […]
FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall
The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time. FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the […]
Dexcom focuses on early diabetes diagnosis as COVID links emerge
New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s […]
Cardinal Health starts Zipline drone deliveries of drugs and medical supplies
Cardinal Health (NYSE: CAH) today started air delivery of pharmaceutical products and medical supplies via Zipline drone in North Carolina. San Francisco-based Zipline won FAA Part 135 air carrier certification for the long-range flights earlier this month. The company flew its first commercial deliveries on June 22 with an initial 16-nautical-mile flight. The flights starting today […]
They said it at DeviceTalks Boston
Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead. Here are some of the most quotable insights from panelists and speakers at our live event. And make sure to save the date — and save your seat […]
Intrommune extends scope of Phase 1 trial for peanut-allergy-treating toothpaste
The food-allergy-focused biotech Intrommune Therapeutics is announcing that it is extending the duration of the ongoing Phase 1 OMEGA clinical trial of INT301 in adults with peanut allergy. The alteration will lengthen the study duration to 48 weeks to include a maintenance period. The study duration was previously 26 weeks. The New York City–based company […]
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff […]
Thanks, dad! Medtech leaders reflect on Father’s Day
Everyone has a story about how they got into medtech, and it’s no surprise that many of those stories start with how we were raised. As Father’s Day approaches, Medical Design & Outsourcing asked medtech leaders to share some thoughts about how their dads inspired their careers, the products they make and the companies they’ve built. We […]
FDA concludes Pfizer-BioNTech vaccine likely safe and effective in kids under 5
In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines […]
