Drug Delivery Business News Archives - Page 2 of 4

EmblemHealth to provide coverage for Senseonics’ Eversense CGM

Senseonics (NYSE:SENS) announced that EmblemHealth is now providing coverage for its Eversense continuous glucose monitoring system.

Germantown, Md.-based Senseonics said in a news release that the immediately effective decision adds to the number of payers writing the Eversense system into their CGM coverage policies and paying for the healthcare provider’s time for the in-office sensor placement.

EmblemHealth, which operates in New York, New Jersey and Connecticut, expands access to approximately 2.9 million residents across the three states with the addition of Eversense to its 2021 CGM policy.

Eversense features a fluorescence-based upper-arm sensor, a smart transmitter worn over the sensor and a mobile app for displaying glucose values, trends and alerts. The system also includes a smart transmitter that provides discreet on-body vibratory alerts and can be removed, recharged and re-attached without discarding the sensor.

“We are excite…

Eitan Medical lands FDA clearance for infusion pump system upgrade

Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories.

The Sapphire infusion system is the company’s flagship infusion device and is used across the U.S. within alternate sites, homecare markets, emergency medical services and hospitals.

The compact Sapphire infusion pump is designed to deliver a wide range of therapies for varied clinical uses, such as saline, total parenteral nutrition, lipids, IV medication, perineural medication, epidural medication, blood and blood products. It has a color touch screen for intuitive and fast operation, built-in safety mechanisms and technology designed to minimize dosage errors and false alarms.

The most recent hardware and software upgrade adds a number of improvements, including:

A perineural route intended to support a wider range …

Senseonics announces $50M from stock offering

Senseonics (NYSE:SENS) announced that it entered into securities purchase agreements worth gross proceeds of approximately $50 million.

Germantown, Md.-based Senseonics’ purchase agreements are with several healthcare-focused investors, as well as other institutional investors, according to a news release.

Investors have agreed to purchase 40 million shares of the implantable continuous glucose monitor maker’s common stock at a price of $1.25 per share, with the proceeds totaling $50 million, although Senseonics expects to collect about $46 million after deducting fees and commissions.

Senseonics said it intends to sue the net proceeds for general corporate purposes after the offering closes on or about Jan. 21, 2021 as the company expects. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

BD stock up on Street-beating preliminary quarterly revenue numbers

Becton Dickinson (NYSE:BDX) today announced that it brought in $5.3 billion in revenue for its first quarter ended Dec. 31, 2020, beating the nearly $4.7 billion expected by Wall Street analysts.

The announcement of the preliminary unaudited Q1 results sent BDX shares up 1.8% to $261.75 apiece by midday trading today. MassDevice’s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.

The Q1 revenue was up 25.6% from the same quarter a year before. Strong demand COVID-19 diagnostic tests played a primary role, but BD also saw better-than-expected performance across all three segments as elective and routine procedure volume showed greater resiliency as a new wave of the novel coronavirus pandemic struck the world.

On top of being an important provider of COVID diagnostic tests, BD is also playing a crucial role in supplying the syringes needed to deliver the newly approved vaccines.

Get the ful…

Abbott wins Medicare reimbursement for FreeStyle Libre 2

Abbott (NYSE:ABT) announced today that its next-generation FreeStyle Libre 2 iCGM is now available to Medicare patients.

The integrated continuous glucose monitoring (iCGM) system met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS), making it accessible to all Medicare patients with diabetes who meet the eligibility criteria, according to a news release.

Abbott Park, Ill.-based Abbott’s FreeStyle Libre 2 includes a sensor worn on the back of the upper arm for up to 14 days, using a handheld reader over the sensor to provide real-time glucose readings, trend arrows and eight-hour history to help healthcare providers and users make informed treatment decisions.

The system also includes real-time alarms and minute-by-minute glucose measurements, while Abbott touts it as the longest-lasting self-applied iCGM sensor currently available, eliminating the need for fingersticks and costi…

FDA approves Medtronic MiniMed 770G insulin pump for young children

(Image courtesy of Medtronic)

The FDA has approved the Medtronic (NYSE:MDT) MiniMed 770G hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years.

The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose monitor values for for such young children, according to the agency. The FDA approved an earlier MiniMed model, the 670G system, for people aged 7 to 13 with Type I diabetes in 2018.

MiniMed 770G System is a Bluetooth-enabled version of the 670G, with other modifications. It works by measuring glucose levels in the body every 5 minutes and automatically adjusting insulin delivery by either administering or withholding insulin. The system includes: a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connect…

B. Braun wins FDA clearance for MRI-safe infusion pumps

B. Braun this week said it received FDA 510(k) clearance for its SpaceStation MRI to allow infusion pumps to continuously deliver medications to patients in an MRI.

SpaceStation MRI is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to protect MR scanners while providing interference-free images. Space infusion pumps are able to safely transition patients into the imaging suite with the SpaceStation MRI, eliminating the need for long infusion lines.

“This clearance allows us to expand our infusion therapy portfolio by providing seamless infusion management across multiple care settings,” B. Braun director of marketing for infusion systems Jonathan Stapley said in a news release. “Our Space Infusion System allows standardization of large volume and syringe pumps on the same workflow with one integration.”

Each SpaceStation MRI holds up to 4 Space pumps and the TeslaSpy continuously monitors magnetic …

Study: Medtronic’s drug-coated balloon reduces dialysis interruptions

Medtronic’s In.Pact arteriovenous drug-coated balloon (Image courtesy of the FDA)

Medtronic (NYSE:MDT) recently announced the results of a study showing that some kidney disease patients who had a drug-coated balloon (DCB) implanted to treat arteriovenous (AV) failure experienced fewer interruptions of dialysis treatment.

Many end-stage renal disease (ESRD) patients require AV fistulae in order to receive continuous dialysis. Blood vessels that feed the access site can narrow over time and patients often undergo multiple maintenance procedures per year to restore access site function. The need for frequent reinterventions can result in repeated hospital visits and significant disruptions to hemodialysis care. By being able to maintain access site patency, patients may experience longer periods of uninterrupted dialysis, according to a news release from Medtronic.

Get the full story on our sister site,…

Tandem Diabetes posts $27m Q2 loss, reinstates earlier guidance

Tandem Diabetes Care (NSDQ:TNDM) posted Street-beating second-quarter sales and missed badly on earnings, but reinstated its earlier full-year 2020 guidance.

The San Diego-based company — maker of insulin pumps and other diabetes management devices — reported a loss of -$27.1 million or -0.45¢ per share, on sales of $109.2 million for the three months ended June 30, 2020, for a bottom-line loss of -17% compared with Q2 2019.

Get the full story on our sister site, MassDevice.

Inovio to scale up production of smart delivery device for potential COVID-19 vaccine

Inovio Pharmaceuticals (NSDQ:INO) announced that it received $71 million from the U.S. Defense Dept. to support its Cellectra 3PSP smart device.

Funding from the DoD is set to support large-scale manufacturing for the Cellectra 3PSP and the procurement of Cellectra 2000 devices, which are used to deliver INO-4800 directly into the skin. It may also be used to deliver a potential COVID-19 vaccine.

The small, portable, hand-held device that runs in “AA” batteries is designed to deliver the INO-4800 vaccine where it prompts the body’s immune system to drive an immune response. It is currently in the midst of a U.S. Phase I clinical trial, for which results will be available later this month. A Phase II/III efficacy trial is slated to begin this month or next.

Plymouth Meeting, Pa.-based Inovio said in a news release that its San Diego manufacturing facility has produced initial quantities of the device and displayed capabilities for scale-…

Thermo Fisher rises on COVID-19 response-driven Q2

Thermo Fisher Scientific (NYSE:TMO) shares got a boost today on second-quarter results that came in well above the consensus forecast.

The Waltham, Mass.-based company posted profits of $1.2 billion, or $2.90 per share, on sales of $6.9 billion for the three months ended June 27, 2020, for a 3.3% bottom-line gain on sales growth of 9.5%.

Adjusted to exclude one-time items, earnings per share were $3.89, a whopping $1.05 ahead of Wall Street, where analysts were looking for sales of $6.13 billion.

Thermo Fisher’s sales growth falls in line with the company’s projections earlier this month, as it said it anticipated 10% growth in revenues. Growth was primarily driven by global sales of PCR-based tests and other products and services supporting the response to the COVID-19 pandemic.

The company received FDA emergency use authorization and CE Mark approval for its SARS-CoV-2 diagnostic test in the early stages of the pandemic back in March…

Smiths Medical lands major vaccine-related contract

Smiths Medical announced today that it has landed a federal contract to produce more than 78 million syringe-and-needle units and $20 million in federal funding to expand its Keene, N.H. plant to produce them.

The Plymouth, Minn.-based company said it received an order for 78.6 million syringe-and-needle units and that BARDA and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense will foot $20 million of the Smiths’ $38 million capital expansion project in Keene. The partnership will increase needle production capacity by 125 million units per year, according to the company. The federal government will have priority access to this expanded capacity for vaccination efforts dedicated to COVID-19, flu vaccines and future pandemics.

“Over the last 6 months, Smiths Medical has delivered the healthcare industry significant increased production of ventilators, infusion pumps, extended dwell catheters and other respirator…