Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]
NuVasive recalls scoliosis treatment devices
NuVasive (NSDQ:NUVA) issued an urgent field safety notice to warn users of an issue with the separation of a certain component in its Magec system model X rods. According to the safety notice, post-implant separation of an actuator end cap component was observed in the rods. Data from post-market surveillance revealed that the end cap separation […]
How will coronavirus affect medtech companies that rely on elective surgeries?
One thing is likely to hurt some medtech companies more than others during the coronavirus pandemic: an elective surgical procedure slowdown. This thought had begun to emerge last week among industry watchers, but a pair of tweets over the weekend gained thousands of “likes” and retweets. The American College of Surgeons called for hospitals to […]
DePuy Synthes wins CE Mark for hip replacement dual mobility system
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes announced that it won CE Mark approval for its Bi-Mentum dual mobility system for people with a higher risk of dislocation. Bi-Mentum is designed with a standard femoral head articulating within a large polyethylene liner that swivels within a metal shell, reducing the risk of dislocation, which can impact patient satisfaction […]
Impulse Dynamics appoints medical director
Cardiac contractility modulation (CCM) therapy developer Impulse Dynamics announced that it is appointing Dr. Ishu Rao as its medical director. Rao previously spent 17 years in a clinical practice treating heart failure patients, with a focus on interventional therapies, according to a news release. He received his cardiology training at Harbor-UCLA Medical Center in Torrance, […]
Medtronic issues urgent field safety notice for some Pipeline Flex embolization devices
Medtronic (NYSE:MDT) issued an urgent field safety notice to warn on specific production lots of its Pipeline Flex embolization devices due to the potential for device fracture. The medtech giant initiated verbal communication about the issue last month after identifying the potential for device fracture at the distal section during use, due to a weakened bond […]
FDA warns on potential cybersecurity weakness in Bluetooth Low Energy medical devices
The FDA issued a statement to warn patients, healthcare providers and medical device manufacturers about potential cybersecurity vulnerabilities in Bluetooth Low Energy (BLE) technology. BLE allows two devices to “pair” and exchange information to perform their intended functions while preserving battery life in all sorts of devices, including medical technology. The vulnerabilities, referred to by […]
Aria completes $31m Series B for its pulmonary hypertension treatment device
Pulmonary arterial hypertension (PAH) treatment developer Aria CV announced today that it completed a $31 million Series B financing round. The proceeds from the round, led by private equity and venture investor Xeraya Capital, are earmarked for funding St. Paul, Minn.–based Aria CV’s first U.S. clinical study. Aria CV’s early feasibility investigational study is set […]
In2Bones launches single-use delivery system for radial head replacement surgery
In2Bones announced today that it began the U.S. launch for its Avenger radial head prosthesis system for primary and revision joint replacement of the radial head. The Memphis, Tenn.–based company’s new prosthesis is designed to restore elbow joint function and offer other advantages for both surgeons and patients when compared to the current prosthetic systems […]
Aria CV wins breakthrough nod for pulmonary arterial hypertension device
Aria CV announced that it won FDA breakthrough device designation for its pulmonary hypertension (PH) system for treating pulmonary arterial hypertension (PAH) that can lead to heart failure. The implanted system is designed to restore the benefits of a healthy, elastic pulmonary artery, according to a news release. The restoration should lead to reduced cardiac […]
In2Bones wins FDA clearance for Quantum total ankle
In2Bones announced today that it won FDA 510(k) clearance for its Quantum Total Ankle system to replace ankles in patients with arthritis. The Quantum Total Ankle’s creators designed it to improve mobility, increase stability and technologically advance implant placement based on patient-specific anatomy, according to a news release. The implant features a dual radius of […]
- 1
- 2
- 3
- …
- 68
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube