Medigate spreads into healthcare IOT

Medical device security firm Medigate said today that it is expanding into clinical IoT and general IoT devices.

The company developed and supports a medical device security and asset management platform designed to identify, tag and fingerprint individual medical devices beyond their IP address. Tags for devices are based on type, vendor and model, and allow for better visibility into types, vendors, protocols and operations systems, Medigate said. Now it says it can enable accurate and comprehensive device discovery, contextual and behavioral anomaly detection as well as clinical policy enforcement for health delivery organizations’ (HDO) entire clinical networks.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Medigate spreads into healthcare IOT appeared first on MassDevice.

from MassDevice https://ift.tt/2Kba49Z

Medical Alley companies beat Q1 investment total

A surge in first-quarter 2019 investments in Medical Alley Association member startups pushed them past their performance in the same quarter last year, according to the Minnesota-based trade group.

Seven of the 10 largest raises of the quarter went to medical device companies, which propelled the sector to its best first quarter on record, nearly doubling the second-best total. The funded companies make products ranging from cardiopulmonary intervention devices to novel orthopedic treatments for both chronic and acute conditions.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Medical Alley companies beat Q1 investment total appeared first on MassDevice.

from MassDevice https://ift.tt/2FHma53

SEC details Fresenius’ $231m FCPA settlement

The U.S. Securities and Exchange Commission today detailed the more than $231 million that Fresenius Medical Care (NYSE:FMS; ETR:FRE) agreed to pay to resolve self-reported violations of the Foreign Corrupt Practices Act.

In its release, the SEC said that it found that Germany-based Fresenius engaged in misconduct in Saudi Arabia, Morocco, Angola, Turkey, Spain, China, Serbia, Bosnia, Mexico, and eight countries in the West African region. The agency added that the misconduct occurred “against a backdrop where the company failed to have sufficient internal accounting controls.”

The company made improper payments through a number of different schemes, according to the SEC, including sham consulting contracts, falsifying documents and funneling bribes through a system of third party intermediaries.

The SEC said that despite having seen “red flags of corruption” since the early 2000s, the company did not devote sufficient resources towards compliance. The agency went on to claim that Fresenius failed to take even basic steps, such as providing anti-corruption training or performing due diligence on its agents.

“In many instances, senior management actively engaged in corruption schemes and directed employees to destroy records of the misconduct. All told FMC paid nearly $30 million in bribes to government officials and others to procure business,” the SEC wrote in its posting.

Fresenius agreed to pay $147 million in disgorgement and interest to the SEC alongside a criminal fine of $84.7 million as part of a non-prosecution agreement that was announced by the Department of Justice last Friday.

Terms of the agreement include a requirement that Fresenius retain an independent compliance monitor for two years as well as the self-reporting of its FCPA compliance efforts for the year after.

“Failure to address the corruption risks in its growing business allowed complicit managers to engage in bribery schemes that went undetected for more than a decade. As companies expand their business, their internal accounting controls and compliance programs must keep up,” FCPA Unit chief Charles Cain said in a press release.

“By engaging in widespread bribery schemes across multiple countries, the company prioritized profits over compliance in its dealings with foreign government officials,” FCPA Unit Enforcement Division Deputy Chief Tracy Price said in a prepared release.

In February, Fresenius Medical Care said that it closed the $2 billion acquisition of NxStage Medical and settled self-reported violations of the U.S. Foreign Corrupt Practices Act for nearly $255 million.

The post SEC details Fresenius’ $231m FCPA settlement appeared first on MassDevice.

from MassDevice https://ift.tt/2Ve2z2U

Angel Medical Systems clears bankruptcy, raises $10m

Angel Medical Systems has raised $10 million in a new equity round of financing after clearing its Chapter 11 bankruptcy plans.

The Eatontown, N.J.-based company developed the FDA-cleared AngelMed implantable cardiac monitor system intended for patients who had prior acute coronary syndrome events, including myocardial infarctions or unstable angina, and who remained at high risk for recurrent ACS events.

Angel Medical Systems won approval for its Chapter II bankruptcy plans in January.

The company said last Friday that it has successfully exited from Chapter II as a private company, adding that the plan was supported by its creditors and that it has converted all existing note holder debt to equity.

“We are delighted to have completed this reorganization quickly. The restructuring resulted in a stronger balance sheet, no debt, and a clear path to commercialization of the AngelMed Guardian, to help patients in the U.S. and around the world,” CEO Dr. David Fischell said in a prepared statement.

“This is great news for those who could benefit from our implantable cardiac monitor and patient alerting system. It means we’re closer to bringing the AngelMed Guardian to market. We want to thank our employees, management team, and stakeholders for their support during the process,” COO Dave Keenan said in a press release.

Angel Medical Systems also said that it has raised $10 million in a new Series A financing round to support its AngelMed Guardian implantable cardiac monitor and patient alerting system.

Money in the round came from 56 unnamed sources, with the first date of sale noted as having occurred on March 29, according to an SEC filing.

The company is looking to raise an additional $5 million in the round, according to the filing.

The post Angel Medical Systems clears bankruptcy, raises $10m appeared first on MassDevice.

from MassDevice https://ift.tt/2JXcqsR

Thank you for 10 great years

MassDevice.com went live on March 30, 2009. In the 10 years since then we’ve launched events, new publications, a print magazine and, with your help, become the #1 outlet covering the medical device industry.

We couldn’t have done it without your support. On behalf of all of us here, thank you for a decade’s worth of medtech news. We’re excited to see what the next 10 years bring!

The post Thank you for 10 great years appeared first on MassDevice.

from MassDevice https://ift.tt/2TOaPoH

3M debuts long-wearing medical adhesive

3M (NYSE:MMM) said that it has added an extended-wear medical transfer adhesive to its lineup of advanced adhesives for medical devices.

Designed to laminate many substrates, 3M medical transfer adhesive 4075 features an extended-wear pressure sensitive-transfer adhesive and allows design engineers to use a variety of backings. The new adhesive also offers up to a 14-day wear time, depending on the backing material used.

Get the full story on our sister site, Medical Design & Outsourcing.

The post 3M debuts long-wearing medical adhesive appeared first on MassDevice.

from MassDevice https://ift.tt/2U6sZXM

Report: Departing FDA head Gottlieb looks back on his time at the agency’s head

Though he only held the position for just under two years, FDA Commissioner Dr. Scott Gottlieb said that he believes the agency’s scope has expanded significantly during his time at its head, according to a FierceBiotech report.

The report comes from a fireside-style chat hosted by the Alliance for a Stronger FDA and the Pew Charitable Trusts in Washington, D.C., according to the report, at which Gottlieb spoke to a group including former FDA head Mark McClellan.

“I think what’s changed most notably about the agency from the time I was there was that the scope has expanded so dramatically, in not a long period of time,” Gottlieb said, according to FierceBiotech.

During his tenure, which began in May 2017, the FDA has expanded its framework to consider how to handle a number of new digital health products, significant advances in regenerative medicine and a changing healthcare landscape, according to the report.

“These are dramatic expansions in the scope of the work that we do. It’s really changed the contours of the agency’s mission, and has made it far more diverse and vast. We actually had to conceive of different ways of regulating,” Gottlieb said, according to FierceBiotech.

Gottlieb also touted that the agency has approved a record number of new drugs under his guidance, reportedly apologizing to the attending former head McClellan for breaking his previously established record.

When asked about the current debate over rising drug prices, Gottlieb said that he will “have a lot more to say on that” after he steps down from the position at the end of this week, according to FierceBiotech.

As for his biggest worries for the agency after he steps away, Gottlieb said that he’s concerned about the possibility catastrophic risks being widely distributed before they’re caught by the federal watchdog, with specific concerns over food products and blood, according to the report.

“I mean, aside from waking up and seeing a tweet about me in the morning – that has always worried me,” Gottlieb said, according to FierceBiotech.

Gottlieb threw his support behind the incoming interim commissioner, current National Cancer Institute head Dr. Norman “Ned” Sharpless, who was tapped to lead the agency last month.

“He’s exceptionally public health-minded, and an outstanding clinician, as well as an inventor himself,” Gottlieb said, according to FierceBiotech.

Gottlieb also said that he has “extreme confidence” in the leadership at the agency, including recently added principal deputy commissioner Amy Abernathy and long-time center directors Janet Woodcock, Peter Marks and Jeffery Shuren, according to the report.

“So all the policy I worked on was formulated in concert with them and their staff. It all came out of the centers, and I think that made it successful. And it made sure that we had a broad consensus around what we were doing,” Gottlieb said, according to FierceBiotech.

The post Report: Departing FDA head Gottlieb looks back on his time at the agency’s head appeared first on MassDevice.

from MassDevice https://ift.tt/2uBHKml