Femasys today announced it received FDA 510(k) clearance for its FemChec contrast-generating device that checks fallopian tubal status. Atlanta-based Femasys designed FemChec for controlled delivery of contrast to confirm tubal status. It alternates between a pattern of saline and air in a continuous stream of contrast media. “FemChec is an essential part of our suite […]
ElectroCore CFO retires, promotes replacement from within
ElectroCore announced this week that Chief Financial Officer Brian Posner will be retiring on October 4. In conjunction with his retirement, the vagus nerve stimulator company announced it promoted Chief Strategy Officer Joshua Lev to the CFO role, effective as of Posner’s retirement. Lev has been with the company since February 2020, when he was […]
LifeVac appoints Laura Bonelli as president
LifeVac this week announced it appointed Laura Bonelli as president of the company. Bonelli was previously the airway clearance device company’s chief marketing officer, where she spearheaded several key marketing strategies that expanded LifeVac’s global reach and brand recognition. As president, she will be responsible for overseeing the company’s day-to-day operations, driving long-term strategic goals […]
Samsara Vision appoints new chief commercial officer
Samsara Vision this week announced it promoted Jason Herod to chief commercial officer. Herod was previously the ophthalmic implant device company’s vice president of commercial and international markets. He joined the company in August 2021 with over 24 years of experience in ophthalmic medical device, pharmaceutical, and over-the-counter business. “When Jason joined Samsara Vision three […]
Novocure CEO to step down, CFO Ashley Cordova named as successor
Novocure today announced CEO Asaf Danzinger will resign from his position, effective January 1, 2025. Danzinger has accepted a new role as senior advisor at the cancer treatment tech company, effective on the same date until early 2026. He has served as Novocure’s CEO since 2002. “It has been a special honor and one of […]
Boston Scientific wins CE mark for Acurate Prime TAVR system
Boston Scientific has received CE mark approval in Europe for its Acurate Prime Aortic Valve System, its newest transcatheter aortic valve replacement technology. Marlborough, Massachusetts-based Boston Scientific designed Acurate Prime with several features to build upon the clinical performance of the Acurate neo2 platform. It has additional valve sizes to expand the treatment range to […]
Inari Medical updates ClotTriever XL catheter instructions for use following reports of injury and death
Inari Medical has updated its instructions for using some ClotTriever XL catheters in a Class I recall due to injury and death reports. The company recalled and updated use instructions after discovering serious adverse events caused by the device entering or blocking the lung arteries. The use of affected products could continue to cause serious […]
BioAffinity Technologies CFO resigns to take on similar role in energy industry
BioAffinity Technologies recently announced that CFO Michael Dougherty has resigned, and J. Michael Edwards was appointed interim CFO. Dougherty is resigning to take on a CFO position in the Pacific Northwest energy industry. He will continue to serve in his role until September 15 and will assist in the transition. BioAffinity Technologies appointed him as […]
Cairn Surgical raises $4.5M for breast cancer locator system
Cairn Surgical this week announced it closed a $4.5 million Series A2 financing round for its Breast Cancer Locator System. Lebanon, N.H.–based Cairn Surgical earmarked the funds to complete the currently enrolling U.S. pivotal trial of the Breast Cancer Locator (BCL) System and implement a limited commercial launch in some European markets. Morningside Ventures led […]
SoClean wins FDA de novo nod for CPAP, ventilation hose cleaner
SoClean this week announced it was granted FDA de novo clearance for its at-home CPAP mask and ventilation hose cleaner SoClean 3+. Peterborough, N.H.-based SoClean designed SoClean 3+ to be used as an adjunct to reduce bacterial populations on certain compatible home-use CPAP masks and ventilation hoses after cleaning. It has demonstrated a 99.9% reduction […]
Si-Bone wins FDA clearance, breakthrough nod for pelvic fixation implant
Si-Bone this week announced it received FDA 510(k) clearance and FDA breakthrough device designation for its iFuse Torq TNT Implant System. The Santa Clara, California-based orthopedic company designed the TNT implant for pelvic fragility fracture fixation and sacroilliac joint fusion. TNT (through and through) is designed to meet the specific anatomical and bone mineral density […]
