Monteris Medical recently raised $35 million as it continues to advance its minimally invasive robotic brain surgery system. The Minnetonka, Minnesota–based company reported a $13.5 million raise in an SEC Form D filed on Sept. 15. But in an article published yesterday in the Star Tribune of Minneapolis, CFO Jim Erickson said the equity financing […]
Owlet seeks FDA clearance for prescription pediatric monitor
Owlet (NYSE: OWLT) announced today that it has submitted a 510(k) premarket notification to the FDA for a new prescription monitoring device for infants. The Lehi, Utah–based company’s device uses pulse oximetry technology. Physicians could prescribe it to assist with in-home monitoring of babies who are patients. Parents receive alerts from the Owlet device when […]
What’s next for the medical device supply chain?
Recent hurricanes in Florida and Puerto Rico provide yet another reminder that the medical device supply chain remains vulnerable to climate change. The COVID-19 pandemic presented its challenges. But as our sister Medical Design & Outsourcing site reported last year, expect superstorms, fires, droughts and other extreme events driven by climate change to continue to […]
New Stryker interbody system uses 3D-printed material
Stryker (NYSE:SYK) today announced the launch of its Monterey AL interbody system for anterior lumbar interbody fusion. The orthopedic device giant said the Monterey AL is the latest addition to its 3D-printed interbody device portfolio. Stryker has 20 years of experience creating porous materials using 3D printing. Its proprietary AMagine process uses additive manufacturing to […]
New medical device user fees agreement passes Congress
The U.S. Congress today sent a stopgap funding bill to President Joe Biden’s desk that includes the reauthorization of FDA user fees programs through 2027. “I am delighted to say that Congress has passed legislation reauthorizing the four user fee programs that provide critical funding to the FDA for its human medical products activities,” FDA […]
Philips shareholders approve new CEO
Roy Jakobs has cleared a final hurdle to become Philips’ next CEO, winning shareholder approval during a special meeting today. The Dutch medtech giant — the fourth-largest in the world according to MassDevice and MDO‘s Big 100 report — announced plans in August for Jakobs to move into the corner office. His appointment is effective […]
Stryker launches Q Guidance system for spine surgery
Stryker (NYSE:SYK) announced today that it has launched its Q Guidance system for spine applications. The FDA cleared the system earlier this year for use in adults, as well as in pediatric patients 13 and up. The system combines new optical tracking options provided by a redesigned camera. It also includes the sophisticated algorithms of […]
Another Philips respiratory devices recall receives a Class I label
The FDA announced today that it is labeling another Philips Respironics recall as Class I, its most serious classification. The new recall involves 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines may contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk […]
Boston Scientific veteran is joining Getinge
Getinge today announced a new EVP of quality compliance, regulatory & medical affairs. Joanna Engelke will also join the Gothenburg, Sweden–based company’s executive team. Her experience includes a decade at Boston Scientific, with her final four years spent as the company’s SVP of global quality and regulatory. Engelke most recently was chief quality officer at […]
ClearPoint Neuro to commercialize FDA-cleared neuro laser
ClearPoint Neuro (Nasdaq: CLPT) announced today that the FDA has cleared its Swedish partner Clinical Laserthermia Systems’ neuro laser therapy system. The plan is for ClearPoint Neuro to commercialize the system as the ClearPoint Prism. The company has exclusive global rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system. […]
Dentsply Sirona has a new CFO
Dentsply Sirona (Nasdaq: XRAY) has hired a new CFO as its board looks to wrap up an internal investigation into past financial practices. Over the past eight years, Glenn Coleman has been CFO and then COO at Integra Lifesciences. Dentsply Sirona announced yesterday evening that Coleman will start as the dental tech company’s chief financial […]