A week after an international group of journalists published a package of stories slamming the medical device industry, the FDA has issued its own report highlighting its accomplishments dating back to 2007. The Medical Device Enforcement and Quality Report touts: Increased medtech manufacturer inspections and voluntary reporting of violative devices and adverse events; Targeted enforcement of […]
Philips recalls lithium-ion defibrillator batteries
Philips Healthcare has issued a worldwide recall of batteries for its HeartStart MRx monitor/defibrillator. The Philips M3538A lithium-ion batteries manufactured from December 28, 2017 to March 20, 2018 for the HeartStart MRx monitor/defibrillator may have an internal component failure and may fail to charge or to provide power, according to a statement by the U.K. Medicines and […]
Boston Scientific sues Micro-Tech over endo clip patents
Boston Scientific has filed a lawsuit against Micro-Tech USA and its Chinese manufacturer, Micro-Tech Nanjing, alleging that Micro-Tech infringed three of its patents for endoscopic hemostatic clips. Boston Scientific claims that Micro-Tech’s SureClip hemostasis clip products infringe the patents for its Resolution and Resolution 360 clips, which are designed to control gastrointestinal bleeding. Henry Schein (Melville, N.Y.) is […]
Ex-Zimmer Biomet SVP loses in court
A former Zimmer Biomet executive has temporarily lost her bid for severance pay and cannot claim company stock options after her 2016 resignation. Robin Barney resigned from her post as a senior vice president claiming a hostile work environment, alleging sex discrimination, breach of contract, and constructive or involuntary discharge. Barney became Zimmer’s SVP of […]
FDA clears Innovative Health to reprocess major manufacturers’ catheters
Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster. The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, […]
FDA delays some UDI compliance dates
Under pressure from manufacturers, the FDA is pushing back Unique Device Identification (UDI) compliance deadlines for some non-sterile, class I, and unclassified devices. Devicemakers will have until September 24, 2020 before they must comply with standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements for these devices, according to the new […]
Is the medical device industry endangering people?
The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny. The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about […]
Dartmouth-Hitchcock hospitals to deploy Philips’ tele-ICU program
Dartmouth-Hitchcock Health (Lebanon, N.H.) has agreed to implement Royal Philips’ (NYSE: PHG) eICU program technology. The program aims to help reduce mortality, length of stay, and ventilation days while providing care to patients wherever they are located. Philips’ eICU is a tele-ICU program that will link specialists at the health system’s flagship hospital, Dartmouth-Hitchcock Medical Center […]
Cerus Endovascular starts European trial of intracranial aneurysm device
Cerus Endovascular said it has enrolled the first patients in a study designed to assess the safety of the company’s Contour neurovascular system, which is designed to reduce the risk of rupture when treating patients with intracranial aneurysms. Intracranial aneurysms occur at the rate of nine per 100,000 with a wide range; in some countries, the rate is […]
Report: Med device recalls down in Q3
Medical device recalls fell by 21% to 284 in the third quarter of 2018, according to a report by Stericycle Expert Solutions. Machine failure was the top cause of recalls based on units, while software led the way based on numbers of recalls, the report says. The total number of medtech recalls for Q3 was lower […]
FDA clears Spinal Elements’ surface coating technology
Spinal Elements said that the FDA has issued 510(K) clearance for the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. The Carlsbad, Calif. company said that a number of products in its portfolio use Ti-Bond, including the most recently introduced Lucent XP height- and lordosis-expandable interbody device. Interbody fusion products with Ti-Bond […]