Siemens Healthineers wins FDA nod for Mammomat mammography system

Siemens (NYSE:SI) Healthineers business said this week it won FDA approval for its Mammomat Revelation mammography system.

The newly cleared mammography system includes the company’s InSpect integrated specimin imaging tool and a new HD breast biopsy solution that allows for one-click targeting of suspicious areas, Siemens said.

The integrated InSpect tool enables imaging and real-time review of biopsy samples at the device’s workstation. Siemens touted that its HD breast tomosynthesis system allows the widest image acquisition angle at 50 degrees.

“Mammomat Revelation is another example of Siemens Healthineers innovation that aids in early breast cancer detection. Building on the industry’s widest angle in breast tomosynthesis, Mammomat Revelation delivers an improved patient experience. For the first time, healthcare providers have next-generation tools that make a real difference in diagnostic certainty,” Siemens Healthineers NA X-ray VP Martin Silverman said in a prepared statement.

Earlier this month, Siemens Healthineers shares gained nearly 7% after raising more than $5 billion in an initial public offering.

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Reva touts first implant of Fantom Encore bioresorbable scaffold in Switzerland

Reva Medical (ASX:RVA) announced today that the company’s Fantom Encore bioresorbable vascular scaffold was used for the first time in Switzerland.

The sirolimus-eluting device, which is made from Reva’s proprietary Tyrocore polymer, features a 95-micron strut profile and x-ray visibility.

Get the full story at our sister site, Drug Delivery Business News.

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Dexcom wins FDA nod for first interoperable continuous glucose monitor

Dexcom (NSDQ:DXCM) shares jumped yesterday after the company scored a unique FDA approval for its G6 continuous glucose monitor, marking the first time the U.S. regulatory agency has cleared a CGM as “fully interoperable” with other medical devices.

The company’s latest CGM also eliminates the need for patients to calibrate the device by pricking their fingers. The patch device, which is about the size of a quarter, is calibrated at the factory and can be worn for 10 days at a time.

Get the full story at our sister site, Drug Delivery Business News.

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Canon Medical wins FDA nod for Aplio i600 ultrasound

Canon (NYSE:CAJ) Medical Systems said today it won FDA clearance for its Aplio i600 ultrasound system.

The newly cleared Aplio i600 is designed to be small and light to improve ease of use and productivity, the company said, and features an image-guided user interface for simpler exam navigation.

Canon said that the newly cleared system also features the company’s iPerformance imaging technology which it claims reduces clutter and improves visualization.

“The Aplio i600 was designed to expand the clinical utility of ultrasound by delivering outstanding image quality that allows health care providers to feel confident in every diagnosis. The cost-effective solution also improves productivity with an intuitive user interface that enhances workflow and reduces training needs,” ultrasound biz unit director Dan Skyba said in a prepared statement.

Earlier this month, Canon said it closed a deal to acquire Dutch medtech dev Fysicon for an undisclosed amount.

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Convexity Scientific launches pocket-sized nebulizer

Convexity Scientific announced today that the company launched its Flyp nebulizer for patients with asthma and chronic obstructive pulmonary disease.

The handheld, pocket-sized device was approved by the FDA in May last year. Convexity’s nebulizer includes a vibrating internal disk that produces an inhaled aerosol mist to deliver medication deep into patients’ lungs.

Get the full story at our sister site, Drug Delivery Business News. 

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Vertiflex ups raise to $45m

Vertiflex has raised a total of $45.3 million in a round of equity financing, according to an SEC filing posted this week.

The first sale in the offering was marked on March 6 last year, and $15.3 million of the funding raised is marked as coming from conversion of debt, according to the SEC filing.

That means that the company has added an additional $20 million in equity financing over its previous raise as reported on March 13, filling the total the company was looking to raise.

Funds in the round came from nine unnamed sources, according to the SEC filing, and Vertiflex has not yet stated how it plans to spend funds raised in the round.

Earlier this month, Vertiflex said it closed a $40 million round of financing to support its Superion indirect decompression system designed to treat moderate lumbar spinal stenosis.

The Superion device, which won FDA approval in May 2015, is designed to be implanted in the spine with a minimally invasive procedure to relieve spinal stenosis, a narrowing of the spine, which can put pressure on spinal nerves. The condition, which is often associated with aging, can cause pain, numbness and loss of certain motor function.

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Boston Scientific lays off nearly 300 from Valencia neuromod facilities

Boston Scientific (NYSE:BSX) has laid off 289 employees at a facility near Los Angeles, according to a WARN report.

The cuts, which were initially reported last November, went into effect on November 28, according to the report.

The facility, located in Valencia, Calif., 40 miles north of Los Angeles, serves as the headquarters for the company’s neuromodulation business.

Cuts were reportedly part of a plan Boston Scientific previously released looking to move jobs from the location to different locations in Minnesota, Puerto Rico and Ireland, according to a Boston Business Journal report.

Approximately 1,200 employees work out of the facility, according the the report, though Boston Scientific did not update on the current number of workers at the facilities.

“Boston Scientific embraces its responsibility to serve as a strong corporate citizen in the communities where our employees live and work, and the company expects to remain an active community leader. This includes supporting initiatives that strengthen the local community and encouraging employees to volunteer their time and expertise to help others,” a Boston Scientific spokesperson told the Boston Business Journal.

Last March, Boston Scientific said it signed a 10-year extension on the lease for the Valencia, Calif.-based facility, looking to continue to operate its neuromod devision out of the 342,000 square foot facility.

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