Bioventus plans to buy CartiHeal for at least $315M to launch knee implant

The CartiHeal Agili-C implant for treating cartilage lesions [Image courtesy of CartiHeal]

Bioventus (Nasdaq: BVS) today said it plans to buy CartiHeal following the FDA’s recent premarket approval of the Israel-based medtech developer’s Agili-C implant.

Durham, North Carolina-based Bioventus will pay about $315 million to buy the company, excluding the stake already owned by Bioventus after it made a $50 million escrow payment last year.

The deal also includes the potential for Bioventus to pay up to $135 million more if CartiHeal is able to hit $100 million in trailing 12-month sales. Bioventus plans to finance the acquisition with debt.

The transaction is expected to close in the second quarter, followed by a limited market release in the U.S. in the third quarter.

CartiHeal won FDA breakthrough designation for the Agili-C implant in 2020 and received FDA premarket approval i…

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Meddux appoints new director of business development

[Image from Meddux]

Meddux announced today that it appointed Margery Parsell as its director of business development.

Parsell previously held the role of business development consultant for The Parsell Group, having worked with contract design services and manufacturing organizations including TDC Medical, Vention Medical, AdvancedCath, TE Medical and Aran Biomedical before that.

She holds more than 25 years in the medical device industry and brings knowledge of the development and manufacturing of complex and innovative devices in cardiology, structural heart, MIS devices, robotics, wearables and energy-based therapeutics, according to a news release.

“We are excited to have Margery join our team as a full-time employee,” Meddux President Dave Schechter said in the release. “Margery’s primary goal will be to serve our current clients, improve communications, and to identify and implement business…

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Freudenberg Medical secures global ISO 14001 environmental management certification

A Freudenberg Medical employee inspects a precision injection molded medical component at the company’s Kaiserslautern operation in Germany. [Photo courtesy of Freudenberg Medical]

Freudenberg Medical said it achieved ISO 14001 certification for its 11 locations in the U.S., Costa Rica, Germany, Ireland and China following a final audit at the company’s new headquarters in Beverly, Massachusetts.

ISO 14001 specifies environmental management system requirements to enhance environmental performance, meet compliance obligations and achieve environmental objectives.

Freudenberg Medical said it is working to reduce its environmental impact and achieve carbon neutrality of its manufacturing activities.

“Freudenberg Medical is a leader in sustainable manufacturing for the medical device and pharmaceutical industry. It is our social responsibility to protect the environment and preserve earth’…

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Philips-backed study says more could be done to treat cardiac device infections

Roughly four in five Americans with cardiac implantable electronic device infections don’t receive recommended treatment, according to a Philips-funded study out of Duke University.

The large-scale, real-world analysis of CMS data also found that complete hardware extraction within 6 days was associated with a 42.9% lower risk of death than among patients who did not undergo device removal. Groups including the Heart Rhythm Society (HRS) have recommended extraction for all patients with a definite CIED infection, including complete device and lead removal.

“This study highlights the life-threatening nature of device infections and the significant opportunities to improve care in these complex patients,” Dr. Jonathan Piccini, the lead investigator of the study and the director of Cardiac Electrophysiology section at the Duke Heart Center, said in a news release. “The findings also emphasize the importance of timely diagnosis and complete treatm…

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FDA approves Abbott’s leadless pacemaker for patients with slow heart rhythms

Abbott (NYSE:ABT) announced today that the FDA approved its Aveir single-chamber (VR) leadless pacemaker for slow heart rhythms.

In November 2021, the Abbott Park, Illinois-based company reported results from an FDA investigational device exemption (IDE) study that showed that Aveir met pre-specified primary endpoints in patients with certain abnormal heart rhythms, suggesting that, if approved, Aveir could aid those who require the use of a pacemaker to treat slow heart rhythms.

Get the full story at our sister site, MassDevice.

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Studies show that iRhythm’s Zio detects AFib early, prevents hospital admissions

iRhythm’s Zio cardiac monitoring device [Image courtesy of iRhythm]

iRhythm Technologies (Nasdaq:IRTC) announced results of multiple studies supporting the use of its Zio technology in detecting AFib.

San Francisco-based iRhythm presented the results of three clinical research studies at The American College of Cardiology’s 71st Annual Scientific Session & Expo.

Get the full story at our sister site, MassDevice.

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Ultrasonically welded flow sensor critical to success of Hamilton Medical ventilator design

The body of the Hamilton Medical proximal flow sensor consists of two molded halves composed of medical-grade plastic. Between the two halves, a ring-shaped insert holds a delicate membrane with a variable orifice that detects changes in air direction and flow within the patient airway, transmitting inhalation/exhalation inputs to the ventilator digital control through two small tubes linked to the ports at center right. These inputs are used to minutely regulate air pressure and flow in real time. [Photo courtesy of Hamilton Medical]

The disposable sensor monitors ventilation of critically ill patients with high precision.

Didier Perret, Emerson

Hamilton Medical (Bonaduz, Switzerland) produces intelligent ventilation solutions for intensive-care units and critical-care transports. To meet the exploding demand for ventilators during the COVID-19 pandemic, Hamilton Medical established a new ventilator produ…

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A Case for Tungsten Cable: Motion Control in Surgical Robots

.019 Ø, 19×19 with plasma welded ends.

Among the most common tungsten cable constructions used in surgical robotics include 8×19, 7×37, and a 19×19 configuration. 8×19 tungsten mechanical cable comprises 201 tungsten filaments, while 7×37 includes 259, and lastly, 19×19 possesses 361 helically stranded wires. And although stainless steel serves a number of applications, including numerous medical and surgical devices, there is no substitute for tungsten cable in surgical robotics applications.

But why is stainless steel, such a celebrated mechanical cable material, less and less popular in actuating motion in surgical robots? After all, stainless steel cable, particularly in miniature diameters, is used ubiquitously across military, aerospace and most importantly to the topic, countless other surgical device applications.

Well, the reason tungsten cable is supplanti…

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Dymax to exhibit at MD&M West

Dymax announced today that it will exhibit at MD&M West from April 12-14 in Anaheim, California.

Torrington, Connecticut-based Dymax specialists will be present in booth 1901 to discuss and demonstrate an array of the company’s light-curing technologies, including See-Cure and Ultra-Red fluorescing.

The company will also be presenting a first-of-its-kind 2000-MW series of adhesives formulated for safer use when in proximity to skin, as well as 1040-M autoclave resistant material for potting and encapsulation and 1172-M-UR material that’s of interest to manufacturers of in vitro diagnostics or applications requiring bonding or sealing of low-surface-energy substrates like COC/COP. The 215-CTH series of catheter bonders will also be available for demonstration.

Dymax’s booth will also feature the company’s redesigned UVCS 3.0 conveyor system along with the Dymax tube bonder system, as well as the company’s latest broad-spe…

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GripAble picks MedLine for exclusive U.S. hand therapy product distribution

The GripAble device connects to a tablet app for in-person or remote therapy. [Photo courtesy of GripAble]

Medline has inked an exclusive U.S. distribution agreement with GripAble, the developer of a two-in-one hand and arm function assessment and training device.

The GripAble Pro was designed to help therapists serve more patients more efficiently in neurological rehabilitation, pediatrics, hand therapy and other applications.

The device connects to a tablet app and tracks grip and release, wrist flexion and extension, pronation and supination, radial and ulnar deviation, overall strength, repetitions and training time. GripAble said its technology platform lets therapists work with patients in person or remotely, and offers better outcomes with interactive activities for motivating patients, real-time biofeedback and rehab progress tracking.

London-based GripAble said its product is used at more…

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New CEO and CFO take over at bone-cutting robot maker AOT

AOT CEO Elmar Zurbriggen (right) and CFO Peter Oprandi with the company’s CARLO system [Photo courtesy of AOT]

Advanced Osteotomy Tools (AOT) announced that Elmar Zurbriggen will become CEO and Peter Oprandi will become CFO effective tomorrow.

Basel, Switzerland-based AOT developed the world’s first certified surgical device to cut bone with a laser. The system is called CARLO, for Cold Ablation Robot-guided Laser Osteotome. 

“Elmar and Peter have both gained decades of experience as senior managers in the life science sector, working for global market leaders such as Johnson & Johnson, Depuy Synthes, AstraZeneca and Lonza,” AOT Chair Dr. Erich Platzer said in a news release. “We are delighted that they are now supporting AOT as CEO and CFO. Our goal is to improve patient care with innovative high-tech products. Elmar and Peter are exactly the right leaders for this.” Read more

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Aidoc’s AI-powered X-ray system cleared to detect collapsed lungs

An x-ray showing pneumothorax [Image courtesy of Aidoc]

Aidoc said today it has received FDA 510(k) clearance for AI-powered X-ray detection of pneumothorax, also known as a collapsed lung.

It’s the latest indication for New York-based Aidoc’s triage and notification system, which has already been FDA 510(k) cleared for flagging suspected intracranial hemorrhage, large vessel occlusions, acute cervical spine fractures, pulmonary embolism, incidental pulmonary embolism, intra-abdominal free gas and rib fractures.

The new offering runs on all X-ray machines (including portable devices) to automatically flag suspected cases of pneumothorax so radiologists and other doctors can act before respiratory or cardiac failure.

“This FDA clearance further validates the breadth of our AI platform, going beyond specific AI algorithms to act as a healthcare AI hub for the enterprise’s cro…

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