Two-and-a-half years after regenerative medicine company Mimedx Group Inc. came under federal investigation for improper sales and marketing practices and nearly two years since it was delisted by Nasdaq, the company is back on track financially and pursuing an active pipeline of new products. Marietta, Ga.-based Mimedx recently reported second quarter sales of $61.7 million, a 7.2% decline from the same period the prior year. The second quarter 10Q Form – one of seven SEC financial statements submitted in the last five months as the company worked to regain compliance – brings Mimedx up to date, paving the way for it to relist its stock.
Tech-enabled diabetes and chronic conditions management company Cecelia Health has secured $13 million in a series B financing led by Rittenhouse Ventures and Endo Investors. Other participants in the round included Boston Millennia Partners, SustainVC and G100 Capital. The funds will be used to speed and further scale adoption of the company’s coaching and telemedicine tools and to build out digital health capabilities.
The U.S. FDA has granted 510(k) clearance to Masimo Corp. for its PVi software tool as a continuous, noninvasive, real-time indicator of fluid responsiveness in select populations of mechanically ventilated adults. PVi, which is an acronym for pleth variability index, quantifies the dynamic changes in perfusion index that occur in a patient during the respiratory cycle.
Keeping you up to date on recent developments in diagnostics, including: GEP tests poor predictors of melanoma recurrence; A nonfasting blood test for diabetes; Starving out Chlamydia.
The U.S. FDA has granted emergency use authorizations (EUAs) to Baxter International Inc. for its HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) during the COVID-19 pandemic. The two sets are intended for use with the company’s Prismaflex or Prismax CRRT monitors.
Israeli startup Bluewind Medical Ltd. has begun enrolling patients at U.S. sites in a pivotal trial of its Renova Istim implantable tibial neuromodulation system for the treatment of overactive bladder.
The COVID-19 pandemic has thrown a wrench in routine medical exams, scaring many patients away from in-clinic visits and diverting resources to coronavirus-related needs. For pregnant women, who require frequent checkups but don’t want to risk infection, this can be a particularly trying time. Now, Israeli startup Pulsenmore Ltd. has launched a hand-held device that lets women perform ultrasounds in their own home and relays the results to a doctor or sonographer for evaluation and feedback.
On-demand mental health company Ginger.io scooped up $50 million in a series D round that was led by Advance Venture Partners and Bessemer Venture Partners. Participants also included Cigna Ventures and existing investors such as Jeff Weiner, executive chairman of Linkedin, and Kaiser Permanente Venture.
People with diabetes are at risk of developing diabetic retinopathy (DR), an eye condition that can cause vision loss and blindness. However, early detection and treatment can slow its progress. To that end, the Food and Drug Administration has cleared the way for Eyenuk Inc. to market its Eyeart autonomous artificial intelligence (AI) system for DR screening in the U.S.
Startup Conformal Medical Inc. has reeled in $85 million in a series C round to support a U.S. pivotal trial of its CLAAS technology, a device designed to seal off the heart’s left atrial appendage (LAA) to reduce the risk of stroke in patients with atrial fibrillation. The financing included participation from new investors Fidelity Management & Research Company LLC and an undisclosed strategic investor.
