Integra LifeSciences (NSDQ:IART) today said it entered into a definitive agreement to acquire ACell. Through the deal, Integra LifeSciences will pay $300 million in cash upfront at closing, subject to customary purchase price adjustments with cash payments of up to an additional $100 million upon certain revenue growth milestones. Columbia, Md.-based ACell currently develops The MatriStem […]
Penumbra recalls some Jet 7 catheters after 14 deaths
Penumbra (NYSE:PEN) has issued an urgent voluntary recall of all configurations of its Jet 7 Reperfusion Catheters with Xtra Flex Technology because the catheter may become susceptible to distal tip damage during use. So far, Alameda, Calif.-based Penumbra has received 14 reports of death related to the problem out of the more than 30,000 distributed units. […]
DJO acquires LiteCure Laser Therapy
DJO today said it acquired LiteCure and its therapeutic laser technology for an undisclosed amount. New Castle, Del.-based LiteCure’s portfolio includes products marketed under the brand names of LightForce Therapy Lasers for humans and Companion for animals. “The LiteCure portfolio was a natural fit for the DJO Recovery Sciences business, bringing together a joint passion […]
ReCor Medical gains FDA breakthrough nod for renal denervation system
ReCor Medical this week announced that its Paradise ultrasound renal denervation system won FDA breakthrough device designation following positive results in a study. The Palo Alto, Calif.-based company’s Paradise system is an investigational device that is designed to treat hypertensive patients who may not be sufficiently responsive to or are tolerant of anti-hypertensive medical therapy. […]
Delcath Systems names operations VP
Delcath Systems recently announced that it appointed Kevin Muir as VP of commercial operations. Prior to joining the company, Muir was the director of sales for the embolic interventional oncology business at BTG, which was recently acquired by Boston Scientific. “We are thrilled that Kevin is joining the Delcath team as VP of commercial operations. […]
Medical Ingenuities gains FDA nod for radial artery occlusion device
Medical Ingenuities today received FDA 510(k) clearance for its radial artery occlusion device called PH Band. PH Band provides real-time feedback to medical personnel monitoring radial artery patency to help prevent radial artery occlusion, according to the Wheaton, Ill.-based company. It can be used in conjunction with a micro Doppler Probe to achieve patent hemostasis […]
Clinical study sponsors may become non-EU post-Brexit
By Ronald Boumans, Emergo Group The departure of the United Kingdom from the European Union on January 1, 2021, has many consequences. Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, as are clinical studies with medicinal products. In this respect, Brexit means that sponsors and […]
Ensemble Orthopedics gains FDA clearance for hand implant
Ensemble Orthopedics recently announced said it received FDA 510(k) clearance for its Ensemble CMC Implant. The implant is designed to treat patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint using a minimally invasive, simple surgical procedure. Ensemble CMC features a saddle shape that replaces the natural bearing surfaces of the carpal and metacarpal bones […]
Zimmer Biomet completes A&E Medical acquisition
Zimmer Biomet today said it completed the acquisition of A&E Medical for $150 million in cash at closing and $100 million in cash payable in 2021. Through the deal, Zimmer Biomet is acquiring the company and its complete portfolio of sternal closure devices, including sternal sutures, cable systems and rigid fixation and a range of […]
NuVasive launches anterior cervical plate
NuVasive today launched its C360 cervical spine portfolio with its Anterior Cervical Plating system. The system features a thin plate measuring 1.6mm and is designed to reduce common postoperative complications like dysphagia, malalignment and adjacent level ossification to allow surgeons to customize treatment to patient needs. “The unveiling of the C360 portfolio reflects NuVasive’s commitment […]
Nevro names VP, investor relations, corporate communications
Nevro (NYSE:NVRO) today said it appointed Julie Dewey as VP of investor relations and corporate communications, effective immediately. Dewey has more than 25 years of experience in investor relations, corporate communications and marketing in several medical technology companies. She most recently served as senior VP and chief communications officer of Wright Medical, which was recently acquired […]