Royal Philips (NYSE:PHG) announced today that it became the first medical device manufacturer to receive a new Underwriters Laboratories (UL) product cybersecurity testing certification. UL designed the UL IEC 62304 certification to provide a framework to evaluate the robustness and maturity of a medical device manufacturer’s cybersecurity controls and capabilities in product development, according to a […]
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Cardinal Health settles China bribery case for $8.8 million
Cardinal Health (NYSE:CAH) has agreed to pay more than $8.8 million to settle charges that a former subsidiary in China failed to detect bribes paid to government hospital officials and employees of state-owned retailers to buy skincare products. The settlement springs from a Securities and Exchange Commission investigation into Cardinal China, which Cardinal Health formed in […]
Insightec raises another $150m for incisionless neurosurgery platform
Insightec announced that it signed definitive agreements for a $150 million Series F financing round with a post-money valuation of $1.3 billion. The Haifa, Israel–based company is the developer of the Exablate Neuro incisionless neurosurgery platform. Insightec touts the Exablate Neuro as the first MR-guided focused ultrasound device to win FDA approval for treating certain […]
FDA asks manufacturers to help prevent protective gear shortages
The FDA said today it wants to hear from surgical mask and gown manufacturers that might be able to increase or speed production to prevent shortages in the U.S. during the COVID-19 outbreak. The agency said it may expedite review of manufacturing site changes or premarket submissions of personal protective equipment, including protective clothing, gowns, […]
Impulse Dynamics appoints medical director
Cardiac contractility modulation (CCM) therapy developer Impulse Dynamics announced that it is appointing Dr. Ishu Rao as its medical director. Rao previously spent 17 years in a clinical practice treating heart failure patients, with a focus on interventional therapies, according to a news release. He received his cardiology training at Harbor-UCLA Medical Center in Torrance, […]
Medtech sterilization business faces battles on many fronts
As the EPA prepares to issue new regulations for the carcinogenic sterilant gas ethylene oxide, the industry must decide whether to invest in expensive emissions-control upgrades, switch sterilization processes or — in the case of some small sterilization companies — exit the business. Nancy Crotti, Managing Editor In the next few months, the U.S. Environmental […]
Neuromod Devices appoints Elsaesser as CCO
Non-invasive neuromodulation technology developer Neuromod Devices announced today that it is appointing Florian Elsaesser as its new chief commercial officer. Elsaesser is a 12-year veteran in the space, having worked extensively in the hearing aid industry, according to a news release. He previously held executive positions at Sivantos and Siemens (NYSE:SI) Audiology. Dublin-based Neuromod Devices said […]
JLL Ventures joins biomed veteran in $100m launch of Renovo Health
JLL Partners announced that it entered into a partnership with Bart Doedens to form Renovo Health, committing $100 million to build the materials technology company. Renovo Health is set up to buy, build and develop materials technologies to improve efficacy across medical and dental procedures with an opportunity for near-term expansion, according to a news […]
Medical device companies continue to scale back sales projections amid coronavirus
Add ConMed (NSDQ:CNMD) to the list of medical device companies scaling back performance projections amid the coronavirus pandemic. The Utica, N.Y.–based minimally invasive surgical device and equipment maker said yesterday that it now expects Q1 2020 revenue growth in the 2–4% range, versus the company’s previous 5–6% guidance. The company also expects a favorable tax […]
Dexcom appoints senior VP of finance and chief accounting officer
Dexcom (NSDQ:DXCM) this week said it appointed Jereme Sylvain as senior VP of finance and chief accounting officer, which took effect on March 9. Sylvain will be the accounting officer for purposes of the rules and regulations of the Securities and Exchange Commission. Prior to his appointment, Sylvain was Dexcom’s VP and corporate controller and […]
Electromed launches SmartVest mobile app
Electromed (NSDQ:ELMD) announced that it launched the SmartVest Connect app for personalized high-frequency chest wall oscillation (HFCWO) therapy management for people with compromised pulmonary function. The app, available on iOS and Android platforms, is designed to securely connect to the SmartVest SQL through Bluetooth technology and allow patients and healthcare teams to track therapy in real-time […]