The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers. The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, […]
Another medtech sterilization plant will close in 2019
A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements. The FDA warned on March 1 about a potential medical device shortage due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. […]
Boston Scientific prevails in employment case
Boston Scientific (NYSE:BSX) has won summary judgment in an employment discrimination lawsuit brought by a former regional manager. Boston Scientific fired the former manager, Michael Simons, in 2015 for impaired job performance due to alcohol consumption, being intoxicated at work events and getting arrested for drunken driving during work hours and failing to disclose the arrest, […]
Ethicon seeks data on Neuwave liver ablations
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it has launched a global registry to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the company’s Neuwave microwave ablation system. The multicenter, observational registry will follow approximately 1,500 patients worldwide for five years from the date of their first liver […]
Thermo Fisher to drop $1.7B on gene therapy maker Brammer Bio
Thermo Fisher (NYSE:TMO) said today that it will acquire gene and cell therapy manufacturer Brammer Bio for $1.7 billion in cash. Brammer Bio is a viral vector contract developer and manufacturer of gene therapies and gene-modified cell therapies for biopharma customers. The Cambridge, Mass.-based business has nearly 600 employees at primary locations in Massachusetts and Alachua, Fla. Get […]
FDA panel: Neuronix Alzheimer’s therapy fails to prove efficacy
An FDA advisory panel has unanimously agreed that the benefits of Neuronix’s NeuroAD system, intended to slow the progress of Alzheimer’s disease, do not outweigh the risks to patient health. Yoqneam, Israel-based Neuonix had applied for de novo clearance of the system. NeuroAD is approved for use in Europe, Australia and Israel, but the FDA panel found […]
NE Ohio biomedical industry investments on the rise
Investment in the northeast Ohio biomedical sector totaled nearly $294 million in 2018 with 71 regional companies receiving funding, according to regional healthcare trade group BioEnterprise. Those figures make this region the third largest for total healthcare investment in the Midwest, following Minneapolis ($664 million) and Chicago ($551 million). These were among the findings of […]
Carbon debuts dental technology platform
3D printing company Carbon unveiled an integrated technology platform for the dental market this week at the International Dental Show in Cologne, Germany. The platform combines software, hardware and materials in an end-to-end solution designed to meet the needs of dental and orthodontic labs and enable them to scale quickly and economically, according to the Redwood […]
Nyxoah sleep apnea neuro-stim therapy gains CE Mark
Nyxoah said it has won the CE Mark for its novel hypoglossal nerve stimulation therapy for treating obstructive sleep apnea (OSA). The Genio system is a battery-free, leadless and minimally invasive neurostimulator designed to deliver bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea patients who have failed conventional continuous positive airway pressure (CPAP) […]
Ex-NuVasive CEO Lucier to head new M&A firm Corza Health
Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets. Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, which owns laser micro manufacturer Resonetics and Sotera Health along with life sciences, technology, and […]
Medical device cybersecurity: It’s time to get real
Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough? Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration. One […]