Reach Neuro announced today that it received FDA breakthrough device designation for its Avantis platform for restoring movement. Avantis uses small electrical impulses delivered to the spinal cord. It helps to restore shoulder, arm and hand movement in individuals with impairment due to chronic stroke. Pittsburgh-based Reach Neuro said its system directly restores a patient’s […]
Pear Therapeutics files for Chapter 11 bankruptcy
Pear Therapeutics (Nasdaq:PEAR) announced today that it filed for protection under Chapter 11 of the U.S. Bankruptcy Code. Boston-based Pear and its wholly-owned U.S. subsidiary each voluntarily filed in the U.S. Bankruptcy Court for the District of Delaware. They intend to pursue a sale of the business or assets under section 363 of the Bankruptcy Code. […]
Philips Respironics recalls some reworked DreamStation devices, deemed Class I by FDA
Issues for Philips (NYSE:PHG) Respironics continue as the FDA deemed a recall of reworked DreamStation devices Class I, the most serious kind. Problems have continued to mount over the past two years or so for the Dutch medtech giant. In 2021, Philips initiated a recall involving millions of CPAP and BiPAP ventilators and other respiratory devices […]
FDA clears patient-specific resection for the Restor3d Axiom total ankle
Restor3d received FDA 510(k) clearance for its Axiom patient-specific resection (PSR) system for use with its Kinos Axiom Total Ankle system. Durham, North Carolina-based Restor3d additively manufactures the Axiom PSR from titanium alloy. The company said this makes it the first all-metal, patient-specific instrumentation system cleared for use with an ankle arthroplasty system. According to […]
Neuronetics enhances NeuroStar connectivity with Wi-Fi capabilities
Neuronetics (Nasdaq:STIM) announced that it implemented improved internet connectivity capabilities across its NeuroStar platform. Malvern, Pennsylvania-based Neuronetics develops products aimed at improving the life of patients with neuro health disorders. Its latest updates to NeuroStar particularly improve connectivity for providers with restricted networks. NeuroStar, a non-drug, non-invasive treatment can improve the quality of life for […]
Abbott FreeStyle Libre reader warning affects more than 4 million devices
The FDA today issued a notice classifying a recall of Abbott (NYSE:ABT) FreeStyle Libre readers as Class I, the most serious kind. Earlier this week, Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The company said it received a limited number of global reports (0.0017%) from users […]
FDA approves diaphragm pacing system from Synapse Biomedical for patients on ventilators
Synapse Biomedical announced that the FDA granted premarket approval (PMA) to its NeuRx diaphragm pacing system (DPS). Oberlin, Ohio-based Synapse designed NeuRx DPS for patients with spinal cord injuries who rely on mechanical ventilation. These spinal cord injury patients can utilize this option when they prefer a more natural method of breathing. Rather than using […]
EvoEndo CEO to leave, replacement named
EvoEndo announced today announced a new CEO and COO along with the departure of previous CEO Heather Underwood. Denver-based EvoEndo, which develops transnasal endoscopy technology, named Jonathan Hartmann as president and CEO. It appointed Ryan Hartman to the COO position. Underwood intends to remain with the company through April to support the leadership transition. Underwood […]
HeartFlow closes $215M Series F funding round
HeartFlow announced today that it closed a $215 million Series F funding round led by Bain Capital Life Sciences. New investor Janus Henderson Investors also contributed to the round. Participating existing investors included Baillie Gifford, Capricorn Investment Group, Hayfin Capital Management, HealthCor, Martis Capital, USVP and Wellington Management. J.P. Morgan acted as the sole placement […]
FDA clears CardioSTAT continuous, ambulatory ECG monitoring tech from Icentia
Icentia announced today that it received FDA 510(k) clearance for its CardioSTAT continuous ECG monitoring system. CardioSTAT relies on a wire-free, single-use recorder. Quebec City, Canada-based Icentia called its technology the leading wearable cardiac monitoring solution in Canada. In 2018, it expanded to the UK. According to a news release, CardioSTAT has been prescribed to […]
Better Therapeutics announces $6.5M private placement
Better Therapeutics (Nasdaq:BTTX) today announced a private placement of nearly 7.9 million shares of its common stock. The San Francisco-based digital therapeutic developer priced the shares at $0.825 per share. That represents the closing price of Better Therapeutics’ common stock on April 5, 2023. The private placement totals gross proceeds of approximately $6.5 million. Better […]