A go-private sale to TPG Capital, valued at $737 million, was completed by Exactech, with all its issued and outstanding stock acquired by TPG. The sale stops the listing of Exactech's common stock on the Nasdaq exchange.
Introducing BSI's Spring Medical Device Roadshow Join experts from BSI, the leading global medical device Notified Body and ISO 13485 registrar, at our half day Mini-Roadshow where you can learn about some of the most significant evolving European regulatory and compliance expectations, to help prepare for impending requirements changes. Cities and dates here.
Becton Dickinson announced the closing of a $100 million deal to sell its soft tissue core needle biopsy devices and Aspira product line to South Jordan, Utah-based Merit Medical. The direct sales force and distribution partners of Merit will be in charge of selling the assets, which include the Temno biopsy system, Achieve programmable automatic biopsy system, Achieve programmable automatic biopsy system and Tru-Cut biopsy needles.
A round of financing pulled in $12 million for Israeli medical device company Perflow Medical, which makes solutions for the treatment of complex neurovascular disorders. The proceeds will be used for commercialization of its first product, the Stream Dynamic Neuro-Thrombectomy Net device, as well as to support development of new products and 510(k) submission.
Genetic Technologies, a molecular diagnostics company in Australia, announced plans to launch a private placement of up to 324.7 million newly issued shares in hopes of obtaining up to approximately $3.56 million. The company added that is in talks with Blockchain Global to create a strategic alliance on the development of medical and biotechnology applications integrating their technologies.
A round of Series B financing brought in $8 million for Israeli gastrointestinal endoscopy devices maker Smart Medical Systems. The money will be used for commercializing the company's G-EYE, an add-on balloon device designed for facilitating colon visualization during adenoma screening.
A Market Research Future report predicts the worldwide artificial disc replacement market will see a compound annual growth rate of 15% through 2023. Key players of the market, which is led by North America, followed by Europe, include Medtronic, Stryker, DePuy Synthes, Smith & Nephew and Zimmer Biomet.
Data from a 105-patient at-home pediatric study of Medtronic's MiniMed 670G hybrid closed-loop diabetes management system showed that compared with baseline data, less glycemic variability, hypo- and hyperglycemia was experienced by patients, with more time spent in the target blood glucose range. Medtronic included the data in its FDA submission to expand indication of the device for use in kids ages 7 to 13.
A study in Diabetes Technology & Therapeutics showed that Senseonics' Eversense continuous glucose monitoring device, which includes an implantable sensor, was safe to use and had more than 93% accuracy in measuring blood glucose levels among patients with type 1 and type 2 diabetes. Researchers evaluated the Eversense CGM as part of the PRECISE II study and also found that the device could be safely inserted and removed by clinicians with limited to no surgical experience after training.
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Medical devices are essential to our modern society. But the companies who make them face strict regulatory, quality and safety standards. To succeed, they must constantly innovate, drive down costs and navigate complex regulatory pathways. Read the Viewpoint.
European regulators gave Edwards Lifesciences CE mark approval for its self-expanding transcatheter Centera aortic heart valve, which is indicated for the treatment of patients with symptomatic aortic stenosis who are at a high risk for open-heart surgery. The valve is intended to be delivered using a 14 French motorized delivery system and is retrievable and repositionable.
Stryker Neurovascular secured expanded clearance from the FDA for its Trevo stent retriever device for use in certain patients with ischemic stroke up to a day after the first appearance of symptoms. Previous clearance for the device was for treating patients six hours after symptom onset.
Feb 26-27, 2018 | Irvine, Calif. This two-day workshop provides attendees the unique opportunity to better understand the FDA perspective on 510(k) submissions, from processes to approval to modifications. Throughout the workshop you'll obtain actionable insights and strategies for assembling and streamlining an effective 510(k) submission. Learn more.