iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant.
Wavre, Belgium-based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, which will enroll over 350 patients with primary open-angle glaucoma.
Get the full story at our sister site, Drug Delivery Business News.
TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote in support of approval for its OCS Liver System.
Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review the premarket approval application for its Organ Care System (OCS) Liver System, a portable organ perfusion and monitoring medical device.
Shares of TMDX were up nearly 13% at $35.79 per share in pre-market trading as the news of the advisory committe’s ruling makes its way around.
Andover, Mass.-based TransMedics said in a news release that the panel voted 14-to-0 in favor of the fact that there is reasonable assurance that the OCS Liver System is effective, with a 14-to-0 vote favoring the fact that there is reasonable assurance of the OCS Liver System’s safety.
Th…
Diversified Medical Healthcare today announced that it has acquired RapidRona and its home wellness testing portfolio.
RapidRona received emergency use authorization in December last year for its SARS-CoV-2 diagnostic test. The home test uses a network of CLIA certified laboratories throughout the U.S. to deliver results to a patient in 48 hours or less.
“We know that Covid-19, unfortunately, is something our population will continue to face,” Diversified Medical Healthcare founder and CEO Kevin Murdock said in a news release. “As recent reports show that the new variants spread faster, cause more severe symptoms, and are causing a decrease in vaccine efficacy, the acquisition of RapidRona is our logical next step in providing necessary solutions for the future of COVID-19. We’re proud to add at-home diagnostic and wellness testing to all that we offer at Diversified Medical Healthcare.”
The RapidRona test kits are designed to provide RT-PCR test results…
Stryker (NYSE:SYK) this week announced that it received FDA 510(k) clearance for its balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears.
Kalamazoo, Mich.-based Stryker designed the InSpace balloon implant to restore the subacromial space without requiring sutures or fixation devices. It has been demonstrated to improve shoulder motion and function, according to the company.
Get the full story on our sister site, Medical Tubing + Extrusion.
Pear Therapeutics today touted results from an extended retrospective analysis of real-world data for its reSET-O prescription digital therapeutic.
Boston-based Pear Therapeutics developed its reSET-O prescription digital therapeutic (PDT) for treating opioid use disorder (OUD).
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CoapTech announced today that it received CE mark approval and an approved CPT procedure code for its PUMA-G ultrasound gastrostomy system.
Baltimore-based CoapTech’s PUMA platform consists of minimally invasive devices designed to enable ultrasound for use in procedures in hollow organs of the body in which it was previously impossible or unsafe to do so, according to a news release.
PUMA-G, the first application of the PUMA platform, holds FDA clearance as a procedural kit allowing bedside clinicians — rather than consultant specialists — to place gastrostomy tubes using solely ultrasound alongside existing skillsets and their teams.
With the newly obtained CE mark approval, CoapTech said it intends to begin a targeted launch of PUMA-G in Europe later this year.
“CE Mark approval allows the PUMA-G System to be sold in Europe and is a major milestone enabling CoapTech’s commercial success,” CoapTech co-founder & CEO Ho…
East End Medical this week announced that it received FDA 510(k) clearance for its SafeCross transseptal radiofrequency (RF) puncture and steerable balloon introducer system.
The Miami-based company designed SafeCross to provide a predictable and safe treatment option for electrophysiology and structural heart interventions requiring left atrial access.
Get the full story on our sister site, Medical Tubing + Extrusion.
TransMedics (NSDQ:TMDX) announced today that the Nasdaq market halted trading of the company’s common stock.
Andover, Mass.-based TransMedics, which develops organ transplant transportation platforms, saw its common stock close down -5.3% at $31.69 yesterday.
The company awaits the outcome of today’s meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review the premarket approval application for its Organ Care System (OCS) Liver System, a portable organ perfusion and monitoring medical device.
Intended to preserve a donated liver in a near-physiologic, normothermic and functioning state, the OCS Liver System also optimizes liver function for eventual transplantation, according to a news release.
The FDA will meet at 9 a.m. ET today to review the PMA application. This story may be updated.
Eli Lilly (NYSE:LLY) announced today that it acquired peptide- and protein-engineering platform developer Protomer Technologies.
Pasadena, Calif.-based Protomer Technologies develops next-generation protein therapeutics designed to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity.
Get the full story at our sister site, Drug Delivery Business News.
The deal, announced today, includes RTI Surgical acquiring Exactech’s FDA-cleared Optecure demineralized bone matrix, used as a bone graft extender in the spine, pelvis, and extremities. RTI Surgical officials think Optecure will complement their portfolio of bone graft substitutes. RTI Surgical offers a portfolio of tissue-based, synthetic and metal implants to OEM customers.
The financial terms of the deal were not disclosed.
“Biologic materials that support joint replacement surgery are an important facet of Exactech’s business,” Exactech CEO Darin Johnson said in a news release.
“This collaboration with RTI allows each company to focus on our unique strengths,” Johnson said. “RTI has specialized expertise…
Italy-based Medical Microinstruments designed the Symani system as a flexible platform with two robotic arms that can be easily positioned for surgical procedures across any anatomical region.
Get the full story on our sister site, Medical Design & Outsourcing.
Stryker (NYSE:SYK) announced today that it launched the Perform humeral stem as part of its newly introduced Tornier shoulder arthroplasty portfolio.
Kalamazoo, Mich.-based Stryker designed its Tornier Perform humeral stem for use in anatomic, reverse and hemiarthroplasty of the shoulder with the aim of allowing for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision, according to a news release.
The design includes four collar diameters and is available in multiple lengths to optimize humeral fit and give surgeons the options to choose, with the focus on smaller stem options allowing for the addressing of smaller patient anatomies with more unique challenges.
Additionally, Stryker made the Tornier Perform compatible with the full line of standard and augmented Perform glenoid options, with Stryker’s Blueprint planning software allowing for surgeons to plan cases in advance with real-time, precise virtual surgery. Read more