MassDevice

Emergo by UL launches 510(k) Builder for streamlined US FDA medical device submissions

February 4, 2020 By MassDevice Leave a Comment

Emergo by UL, a global medical device and healthcare technology consultancy, has rolled out 510(k) Builder, a new subscription-based software tool to simplify and streamline medical device … [Read More...]

How Digitization Can Help Life Sciences Manufacturers Amplify Lean Principles

January 30, 2020 By MassDevice Leave a Comment

By Dave Edwards, Executive Vice President, MasterControl Life sciences manufacturing in 2019 is a dynamic, immensely competitive space in which new markets, ever-changing regulations and … [Read More...]

DePuy Synthes and Orthofix settle customer-poaching lawsuit

Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes has settled its lawsuit over alleged … [Read More...]

Wearable insulin delivery device maker Valeritas files for Chapter 11, selling company

Valeritas (NSDQ:VLRX) announced that the company and its subsidiaries filed voluntary petitions for … [Read More...]

How Elizabeth Holmes may try to beat the rap over Theranos

From saying that blood tests errors are a fact of life to claiming that no one was harmed, there's a … [Read More...]

Sterigenics accused of moving $1.3 billion to avoid ethylene oxide payouts

Attorneys for Illinois plaintiffs suing Sterigenics claim the company deliberately shuffled $1.3 … [Read More...]

Homeland Security updates cybersecurity warnings involving some Medtronic products

The U.S. Department of Homeland Security (DHS) has updated cybersecurity warnings on multiple … [Read More...]

Ex-Sanovas CEO convicted in $2.6m fraud case

A federal jury in San Francisco convicted former Sanovas president & CEO Larry Gerrans this week … [Read More...]

BREAKING: J&J ordered to pay $344m in California pelvic mesh case

A California judge ruled today that Johnson & Johnson and its Ethicon subsidiary must pay $344 … [Read More...]

Integer expands to Israel

Integer Holdings (NYSE:ITGR) today announced it has acquired medtech manufacturer Inomec, formally establishing its presence in Israel. The Plano, Texas-based company said the acquisition will enable it to create an R&D and sales center in the region and adds important catheter design, clinical and pilot manufacturing capabilities to its portfolio. “Acquiring Inomec strengthens our research and development […]

Baxter completes Seprafilm acquisition

Baxter (NYSE:BAX) today said it completed the acquisition of Seprafilm Adhesion Barrier and its assets from Sanofi in a deal worth $350 million. Seprafilm is used as an adjunct to reduce the incidence, extent and severity of adhesions in pelvic and abdominal surgeries, according to the company. It is commercially available in the U.S., Japan, […]

Medtronic seeks to boost surgical robotics play with Digital Surgery acquisition

Medtronic (NYSE:MDT) announced today that it has acquired Digital Surgery (London), a privately-held pioneer in surgical artificial intelligence, data and analytics, and digital education and training. Financial terms of the deal were not disclosed. Medtronic said the purchase will strengthen its robot-assisted surgical platform and its broader portfolio. The medical device giant is making a big play […]

Wearable insulin delivery device maker Valeritas files for Chapter 11, selling company

Valeritas (NSDQ:VLRX) announced that the company and its subsidiaries filed voluntary petitions for Chapter 11 bankruptcy, having agreed to sell substantially all of the business to Zealand Pharma (CPH:ZEAL). The agreement is slated to provide a total cash consideration of $23 million along with certain liabilities related to the ongoing business. Once the acquisition is completed, Zealand […]

Intuitive Surgical acquires Orpheus Medical to expand informatics offerings

Intuitive Surgical (NSDQ:ISRG) announced that it completed the acquisition of privately-held Orpheus Medical for an undisclosed amount to grow its integrated informatics platform. New York-based Orpheus Medical offers information technology connectivity and expertise in processing and archiving surgical video to hospitals around the world. The company develops and distributes a clinical video management and analytics platform […]

Verily, Santen do a JV for ophthalmological devices

Santen Pharmaceutical (OTC:SNPHY) and Verily, an Alphabet (NSDQ:GOOGL) company, announced that they are entering into a joint venture to focus on applying microelectronics and scalable digital technologies to ophthalmology. Osaka, Japan-based Santen and San Francisco-based Verily say they want to improve eye health globally. According to a news release, the joint venture is slated to combine […]

Orthofix to acquire Fitbone limb lengthening system

Orthofix Medical (NSDQ:OFIX) announced that it completed an asset purchase agreement with Wittenstein SE to acquire the assets associated with the Fitbone limb lengthening system for $18 million. Lewisville, Texas–based Orthofix also acquired other potential applications of the technology, which are in preliminary development, including the Fitspine system for early-onset scoliosis. The agreement consists of $18 […]