Hologic this week announced an effort to improve healthcare for Black and Hispanic women in the U.S. Project Health Equality (PHE) will focus initially on how Black and Hispanic women experience healthcare in different regions of the country and on making meaningful, sustainable improvements, according to the Marlborough, Mass.-based company. Hologic’s partners in the $20 million initiative […]
Bose jumps into hearing aid market
Bose just introduced FDA-cleared, direct-to-consumer hearing aids for adults with mild to moderate hearing loss. Users can use a smartphone app to fit, program and control a SoundControl hearing aid without a doctor visit, hearing test or prescription, according to Framingham, Mass.-based Bose. Each hearing aid will retail for $849.95 starting May 18th in five […]
Insulet sues Roche over diabetes tech patent
Insulet (NSDQ:PODD) is suing Roche Diabetes Care in the U.K., claiming that Roche prematurely began selling tubeless insulin pumps covered by an Insulet patent three years before that patent expires. The trial for the lawsuit, filed in August 2020, began this week in the U.K. High Court. Get the full story on our sister site, Drug Delivery Business […]
Medtronic HeartWare instructions recall is serious
Medtronic (NYSE:MDT) is recalling its HeartWare instructions for use and patient manual due to risks from dropping the case, incorrect installation and misinterpretation of an alarm signal. FDA today designated the recall as Class I, its most serious level of recall. The HeartWare ventricular assist device (HVAD) is used as a bridge to heart transplants in […]
Think Surgical robot can use Ortho Development implants, FDA says
The FDA has cleared two Ortho Development knee implants for use with a Think Surgical robotic system, the companies announced today. Surgeons will now be able to use Ortho Development’s Balanced Knee system (BKS) and BKS TriMax implants with Think Surgical’s TSolution One total knee arthroplasty system. TSolution One is the only commercially available active robot system for total […]
Women execs to discuss leadership during pandemic
AdvaMed’s Women’s Executive Network has scheduled a one-day leadership conference for Wednesday, May 19. Future of Medtech: Leading with Resilience, Agility and Empathy will be a virtual event featuring a range of executives from the medical device and corporate world to discuss issues pertaining to leadership throughout the COVID-19 pandemic. Get the full story on […]
New ethylene oxide regulations now expected in 2022
The EPA now estimates that it will propose new regulations for medical device sterilizers’ emissions of ethylene oxide (EtO) in 2022. The agency issued an advance notice of proposed rulemaking for the commercial sterilizers in December 2019 but has not produced the proposal. Now the EPA’s inspector general wants the agency to conduct a new residual […]
Ocular Therapeutix misses The Street on bottom-line leap
Ocular Therapeutix (NSDQ:OCUL) reported first-quarter results that missed the consensus forecast on Wall Street. The Bedford, Mass.–based eye disease therapeutic developer posted profits of $3.12 million, or $0.04 per share, on sales of $7.34 million for the three months ended March 31, 2021, for a bottom-line leap of 114% on sales growth of 181% compared […]
Lilly partners with four companies on insulin pen tech
Eli Lilly (NYSE:LLY) today announced deals with four companies whose diabetes management tech will work with Lilly’s latest insulin pen. The Tempo Pen is a modified version of Lilly’s existing prefilled, disposable insulin pen to which the Tempo Smart Button — in late-stage development – attaches. Through these new agreements, the Tempo Smart Button will […]
Cerapedics’ bone graft gains FDA breakthrough nod
Ortho-biologics company Cerapedics announced that it has won FDA breakthrough device designation for its investigational P-15L bone graft to treat degenerative disc disease (DDD). The company plans to enroll at least 270 DDD patients in the Aspire study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L bone graft […]
FDA revokes Battelle mask decontamination EUA
The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers. In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. […]