Boston Scientific (BSX) received FDA clearance and the CE Mark for its Direxion Torqueable Microcatheter. The catheter is the company’s newest addition to its peripheral embolization medical device technology portfolio. Radiologists use peripheral embolization to treat liver cancer and uterine fibroids, among other conditions. “It involves deliberately blocking a blood vessel to prevent blood flow to […]
Could the answer for diabetic ulcers and other chronic wounds be found under the sea? A new wound healing treatment is one part tissue regeneration technology and one part Little Mermaid. It isn’t often FDA device approval news makes us wow, particularly if it’s a 510(k) clearance. But an Icelandic healthcare startup, Kerecis, got FDA clearance […]
Mobile technology has dramatically changed how many people and industries do work, and it is revolutionizing medical device sales — or it at least has the potential to. Properly implemented, and especially used in conjunction with medical devices sales CRM systems, mobile devices and apps can improve the efficiency and productivity of sales reps as […]
The use of robotic surgical systems is expanding rapidly, but hospitals, patients and regulators may not be getting enough information to determine whether the high tech approach is worth its cost. Problems resulting from surgery using robotic equipment—including deaths—have been reported late, inaccurately or not at all to the Food and Drug Administration, according to […]
EndoChoice, an Atlanta, Ga.-based healthcare startup, announced it’s received 510(k) clearance for its Fuse Gastroscope. It’s not the first positive FDA device approvals news the company has gotten this year either: It received FDA clearance for its Fuse Colonoscope in May. The gastroscope expands the physician’s range of view from about 140 degrees to 245 […]
Medtronic (MDT) presented such good results from its pivotal trial on the CoreValve at the Transcatheter Cardiovascular Therapy conference, the company announced the FDA will consider device approval without the company enduring an advisory panel. This almost imminent FDA device approval makes shaky ground for Edwards Lifesciences (EW), Medtronic’s legal sparring partner and the company […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Glooko, Inc. received an FDA nod for its Android compatible version of its next-generation diabetes management system. According to a company statement, this system is now “the only FDA-cleared mobile diabetes management system that supports the transfer of blood glucose data direct from dozens of compatible glucose meters into many Android devices.” The cloud-based management […]
Neuros Medical, a Cleveland-based medical device company, received an FDA investigational device exemption approval to begin a clinical study on its technology for intractable limb pain management for amputees. According to the company website, the Altius System High Frequency Nerve Block technology “consists of an electrode (also known as a lead) placed around a peripheral […]
After a difficult premarket approval process and tenuous relationship with the FDA, Atlanta’s CardioMEMS received a mixed message from an FDA advisory panel on its CHAMPION HF Pressure Measurement System, an implantable sensor monitor to help guide treatment in patients with congestive heart failure. The panel voted unanimously that the device was safe, the majority […]
Chattanooga, Tenn.-based Advanced Catheter Therapies received FDA 510(k) clearance for its Occlusion Perfusion Catheter, a multi-lumen balloon catheter on Tuesday. The medical device technology can measure pressure inside the treatment chamber, as well as “its inflow and outflow ports for chamber evacuation, filling and flushing,” according to a press release. The catheter is designed to […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Biotronik, an Oregon-based cardiovascular medical device company, announced it received final FDA device approval for its Ilesto DX, an implantable cardiac defibrillator. Earlier this year, it received FDA device approval for family of implantable cardioverter-defibrillator and cardiac resynchronization therapy defibrillators. This week’s approval is an “upgraded” device. This “smaller, thinner” new generation platform allows for a […]
Cost effectiveness and outcomes drive value for payers, Cigna‘s Chief Medical Officer Alan Muney said. While some medical device companies assume an FDA approval will mean a definite reimbursement nod from payers, these two forces drive a sometimes wrongheaded “gap of hopefulness” for the industry. (See his discussion of why device companies need to think […]
IMARC and CardioMed have partnered to offer an exclusive training specifically geared to explain the FDA approval process for cardiovascular clinical trials. Drawing on expert speakers from the cardiovascular device industry and formerly of the FDA, this intermediate-level training program will guide attendees through the process of going from product idea through clinical development and approval.
The third generation of Given Imaging‘s PillCam SB got FDA approval today, and President and CEO Homi Shamir said the product should launch in October of this year. The device, a capsule with a camera inside which the patient swallows takes more than 60,000 images before it exits the digestive system. As the Israel-based continues […]
Medtronic makes history in neurostimulation devices today, receiving FDA-approval for the first implantable spinal cord stimulation systems for use in the treatment of back pain for conditionally safe full-body MRI under specific conditions. Its RestoreSensor® SureScan® MRI neurostimulation systems will allow patients with the implant to undergo an MRI, previously impossible due to the magnetic fields […]
