The FDA last month granted 510(k) clearance to the Ares robot-assisted bronchoscopy platform developed by stealthy Auris Surgical Robotics. San Carlos, Calif.-based Auris was co-founded by medical robotics pioneer Dr. Frederic Moll, who’s behind a slew of other startups in the space, including market leader Intuitive Surgical (NSDQ:ISRG); Mako Surgical, acquired in 2013 for $1.7 billion by Stryker (NYSE:SYK); Restoration Robotics and […]
Respiratory
Respiratory Motion wins CE Mark for ExSpiron minute ventilation monitor
Respiratory Motion said today it won CE Mark approval in the European Union for its ExSpiron non-invasive patient minute ventilation monitor. The ExSpiron patient monitor is designed to improve titration of opioids in postanesthesia care units and in general wards, and to alert attendants to respiratory depression in patientsadministered anesthetics during sedation cases, theWaltham, Mass.-based […]
Propeller Health, Vectura ink collaborative connected-inhaler deal
Propeller Health said today it inked a collaborative development deal with inhaled pharmaceutical company Vectura Group to develop a digitally-connected inhaler system. Through the collaboration, the companies will combine Vectura’s dry powder inhaler with Propeller’s digital health platform. Initial development will focus on an add-on sensor for Vectura’s lever-operated multi-dose inhaler, U.K.-based Vectura said. “This announcement […]
U.S. trial test machine that ‘reconditions’ lungs outside body
(Reuters) – A machine that ‘reconditions’ a donor’s lungs outside the body before being transplanted into a recipient is undergoing tests in the United States in the hope that it can radically improve survival rates for people with chronic respiratory diseases. The XPS, manufactured by Swedish company XVIVO Perfusion , is in clinical trials at […]
ITC opens probe of China’s BMC Medical in patent war with ResMed
The U.S. International Trade Commission yesterday opened a probe into BMC Medical‘s importation of sleep apnea devices, as the long-running patent infringement war between the Chinese company and ResMed (NYSE:RMD) grinds on. ResMed asked the ITC to investigate BMC and its U.S. distributor, 3B Medical, alleging that the Lunaflow and RESmart flow generators for its continuous positive airway pressure devices infringe a quartet of […]
Lungpacer Medical hits the FDA fast track with phrenic nerve pacer
Lungpacer Medical said it won an expedited access pathway designation from the FDA for the diaphragm pacing system it’s developing to treat patients who can’t be weaned from mechanical ventilation. The Lungpacer DPS device is a neurostimulation system designed to exercise and strengthen the diaphragm via the temporary, transcatheter stimulation of the phrenic nerve. The FDA’s […]
Update: BMC continues spat with ResMed over CPAP patents
Updated with comments from ResMed & 3B Medical. BMC Medical today claimed the approval of a motion for a voluntary dismissal of an appeal from ResMed (NYSE:RMD) in a long running patent spat as a win for the company. The dispute is part of a long-standing conflict between the 2 companies over patents related to continuous positive […]
ResMed closes $800m Brightree buy
ResMed (NYSE:RMD) said it closed the $800 million acquisition of cloud-based healthcare software company Brightree yesterday. Atlanta, Ga.-based Brightree develops cloud-based software for home or durable medical equipment for home health and hospice care. Its majority owner was private equity shop Battery, which bought its stake in 2008. “This acquisition furthers ResMed’s position as the leading tech-driven medical device company and […]
FDA: Don’t use OxySure’s portable oxygen generator
The FDA today released a safety letter warning against the use of OxySure Therapeutic’s Portable Emergency Oxygen System model 615. The safety communication comes based on complaints of adverse events related to insufficient oxygen flow, re-breathing of exhaled gases, burns, bruising and exposure to chemicals. The federal watchdog said that over 1,000 of the units […]
Philips Respironics settles kickbacks case for $35m
The Respironics division at Philips (NYSE:PHG) agreed to pay $34.8 million to settle U.S. Justice Dept. claims that it paid kickbacks in the form of free call center services to induce suppliers into buying its sleep apnea masks. Today’s settlement resolves a whistleblower lawsuit filed by South Carolina pharmacist Dr. Gibran Ameer, who worked for medical equipment suppliers that bought […]
CardiacAssist wins 510(k) for TandemLung
CardiacAssist said today it won FDA 510(k) clearance for its TandemLung oxygenator designed to operate as an artificial lung by infusing oxygen and removing carbon dioxide from the blood. The Pittsburgh, Penn.-based company said the TandemLung is designed so it can be used along with its TandemHeart blood pump, and combined the devices “represent a leap […]