Getinge this week announced a major FDA clearance and the beginning of a U.S. launch of multiple surgical tools. The Gothenburg, Sweden-based company won 510(k) clearance for its Vasoview Hemopro 3. This adds to the company’s portfolio of endoscopic vessel harvesting (EVH) solutions. Getinge said it designed the system with customer centricity top-of-mind. It hopes […]
Getinge
Getinge appoints Agneta Palmér as CFO
Getinge announced today that it appointed Agneta Palmér as chief financial officer. Palmér will succeed Lars Sandström, who is leaving the company for a new opportunity outside of the company. Palmér most recently was the EVP of operations services at Getinge and has been with the company since 2018. ”I am very pleased that Agneta […]
Getinge makes infection prevention play with Healthmark buy
Getinge announced today that it has acquired Healthmark Industries, a Fraser, Michigan–based provider of instrument care and infection control consumables. The Swedish medtech company paid $320 million in cash for 100% of Healthmark. The acquisition aims to bolster Getinge’s footprint in the U.S. sterile reprocessing market while paving the way for Healthmark’s global expansion. The […]
Getinge subsidiary Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice labeling another recall of Getinge subsidiary Datascope’s Cardiosave pump as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs). Both devices were subject to two separate Class I recalls in March. The company also initiated a Class I […]
FDA clears non-invasive mechanical ventilator from Getinge
Getinge announced today that the FDA cleared its Servo-air Lite wall gas-independent, non-invasive mechanical ventilator. Gothenburg, Sweden-based Getinge designed the turbine-driven ventilator to offer ICU-quality ventilation. However, its non-invasive nature gears it more toward spontaneously breathing patients in need of extra breathing support. The ventilator features a powerful turbine and long-lasting battery backup power. Getinge […]
Getinge’s Datascope has its second Class I recall in a month
The FDA issued a notice determining another recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The company also initiated recall that […]
Getinge’s Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice determining a recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in December […]
Getinge acquires Ultra Clean Systems for $16M
Swedish medtech company Getinge announced today that it will pay SEK 170 million ($16 million) to acquire Ultra Clean Systems and its ultrasonic cleaning tech. Getinge has already been the exclusive North American distributor of Tampa, Florida–based Ultra Clean Systems’ offerings for nearly a decade. Health providers use ultrasonic cleaning tech in hospitals and surgery […]
Getinge launches new ventilator
Getinge this week launched its new Servo-c mechanical ventilator that offers lung-protective therapeutic tools for pediatric and adult patients. The company aims for Servo-c to make healthcare accessible and affordable for more hospitals, according to a news release. Its design simplifies respiratory support, Getinge said. “Lung protection challenges come in many shapes and sizes,” said […]
MDR reportedly causing medtech companies to leave EU market
The EU’s new Medical Devices Regulation (MDR) has created enough compliance costs that some medtech companies have stopped selling there., according to a report from Reuters. Reuters spoke with eight companies, including the Swedish medtech giant Getinge, who are either withdrawing from the EU market or have stopped making medical devices. The costs of complying […]
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 […]