Final FDA rules clarify adverse event reporting for contract manufacturers

The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burden for contract manufacturers. The federal safety watchdog’s draft guidance for “Medical Device Reporting for Manufacturers,” issued in July 2013, put both the contract manufacturer and its customer on the hook for reporting adverse

Wearable generator that harvests heat could power devices

Researchers at North Carolina State University developed a wearable that can harvest body heat to power devices with at least 20 times the efficiency of other methods, the school reported yesterday. The study, published in the journal Applied Energy, was conducted at the National Science Foundation’s Nanosystems Engineering Research Center for Advanced Self-Powered Systems of

Private equity player Vance Street Capital acquires Motion Dynamics

Private equity player Vance Street Capital said it invested an unspecified amount in Motion Dynamics Corp. and its wire-based components business. Los Angeles-based Vance Street said Motion Dynamics is the 2nd investment out of its 2nd fund, reportedly targeted at $350 million. The 1st investment, medical device OEM A&E Medical, was announced in February. Fruitport, Mich.-based Motion Dynamics

OEMs get in on $10m Series C for biosensor maker HMicro

HMicro said today that “dominant strategic OEM partners” joined a $10.2 million Series C round for the biosensor platform it’s developing for commercialization. Fremont, Calif.-based HMicro makes “system-on-a-chip” biosensors for medical device companies. Existing backers XSeed Capital, Seraph Group and Uniquest also joined the round, the company said. “This strategic investment by new OEM partners who will

Report: Genstar Capital shops Tecomet for $1B

Private equity player Genstar Capital is reportedly shopping Tecomet to potential buyers for more than $1 billion. Genstar tapped investment bank William Blair & Co. to auction Tecomet, according to Reuters, which cited “people familiar with the matter.” Genstar, Tecomet and William Blair declined to comment. Wilmington, Mass.-based Tecomet, founded in 1963, is a contract manufacturer

Vention Medical boosts footprint in Ireland

Vention Medical said today that it boosted its footprint on the Emerald Isle with the opening of a new facility on the National University of Ireland’s Galway campus. South Plainfield, N.J.-based Vention also has an extrusion and catheter-making operation in nearby Boyle, Ireland, the company said. The Galway facility will offer medical device design & development services

Confluent Medical Technologies acquires EME Medical’s textile, polymer businesses

Confluent Medical Technologies, formed last year when Nitinol Devices & Components acquired Interface Catheter Solutions, last week said it closed another buyout for an unspecified amount. Fremont, Calif.-based Confluent said it acquired ETE Medical and subsidiaries Biomedical Structures, which makes biomedical textile implants, and Modified Polymer Components, which makes precision polymer components. “The acquisition of Biomedical Structures and Modified Polymer

FlexDex Surgical closes $5m Series B, preps launch of laparoscopic tools

FlexDex Surgical said today that it raised a $5 million Series B round it plans to use to advance the laparoscopic surgery tools it’s developing. The round was led by current investors, including co-founders technology chief Shorya Awtar, chief marketing officer Greg Bowles and Dr. James Geiger of the University of Michigan; plus board members, individual

TE Connectivity gains on Q3 earnings beat

TE Connectivity (NYSE:TEL) shares are up today after the contract manufacturing giant beat expectations with its fiscal third-quarter earnings and said it would acquire German connector maker Intercontec Group. Schaffhausen, Switzerland-based TE Connectivity posted profits of $839 million, or $2.19 per share, on sales of $3.12 billion for the three months ended June 24, for a bottom-line

Nelipak picks up thermoformer Tegrant Alloyd Brands from Sonoco

Nelipak said today that it acquired a thermoforming company in Puerto Rico, Tegrant Alloyd Brands, from Sonoco for an undisclosed amount. Cranston, R.I.-based Nelipak said Tegrant Alloyd, which makes rigid packaging, sells to medical device and pharmaceutical companies in Puerto Rico and the Dominican Republic. Based in Juncos, Puerto Rico, it will operate under the

Teleflex Medical OEM opens new customer center in Ireland

Teleflex Medical OEM said today that it opened a new center in Limerick, Ireland, for its diagnostic and interventional catheter customers. Citing research showing that some 60% of a product’s cost is created during the design phase, Wayne, Pa.-based Teleflex Medical OEM said its Irish customer center’s team uses a 9-step process for quick-turn concept

Trelleborg picks up Specialty Silicone Fabricators

Trelleborg said that its Trelleborg Sealing Solutions business agreed to acquire Specialty Silicone Fabricators for an undisclosed amount. Tustin, Calif.-based SSF, which makes high-precision silicone components for medical device OEMs, has plants in Tustin, Paso Robles, Calif., and Elk Rapids, Mich., Trelleborg said. SSF posted sales of about $39.1 million last year (SEK330 million). The Swedish polymer

Stratasys CEO Reis to step down

Stratasys (NSDQ:SSYS), which offers 3D printing services to the medical and other industries, said today that CEO David Reis is slated to step down June 30, to be replaced by board member Ilan Levin. Reis was in the corner office at Stratasys for 6 years, helping to oversee the 2012 merger and integration with photopolymer

Secant Group aims for contract manufacturing space with rebrand

Secant Medical said today that’s rolling up its medical, technical and medical device contract manufacturing businesses and rebranding as Secant Group. The combination of Secant Medical Components, Secant Technical Materials and SanaVita Medical targets the medical device, pharmaceutical, space and energy markets, the Telford, Pa.-based company said. “Our mission is to use advanced materials and process technologies

WinMed looks to license or sell VariSoft guidewire

WinMed is looking for a buyer for the VariSoft guidewire developed by founder & CEO Ed Winters, inking a deal with medical device incubator Hatch Medical to broker the sale or licensing of the device. Atlanta-based Hatch Medical said the VariSoft device is designed to be soft and flexible enough to navigate twisting blood vessels to